ELITechGroup Inc
Registration 1717966FEI 1717966LOGAN, UT
Owner/operator: ELITechGroup Inc.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 37
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 37
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| LCP | Direct A1c Calibrator KitAssay, Glycosylated Hemoglobin | Class 2 | 21 CFR 864.7470 | K031539 |
| JIX | Carbon Dioxide Electrode, REF 3918-003Calibrator, Multi-Analyte Mixture | Class 2 | 21 CFR 862.1150 | — |
| JIX | Chloride Electrode, REF 3918-006Calibrator, Multi-Analyte Mixture | Class 2 | 21 CFR 862.1150 | — |
| JIS | Sweat-Chek Calibrator, 90 mmol/L, 60x0.75mLCalibrator, Primary | Class 2 | 21 CFR 862.1150 | — |
| JIS | FreezePoint® Calibration Standard, 300 mOsmol/kg, 10x0.8mLCalibrator, Primary | Class 2 | 21 CFR 862.1150 | K032608 |
| JFS | ChloroChek® Chloridometer® Sweat Chloride Analyzer, Model 3400Coulometric, Chloride | Class 2 | 21 CFR 862.1170 | K121823 |
| KTB | Macroduct® Advanced 3710 Sweat Collection SystemDevice, Iontophoresis, Specific Uses | Class 2 | 21 CFR 890.5525 | K180627 |
| KTB | Macroduct CollectorDevice, Iontophoresis, Specific Uses | Class 2 | 21 CFR 890.5525 | K853973 |
| KTB | Nanoduct® Attachment Strap Retainer PostDevice, Iontophoresis, Specific Uses | Class 2 | 21 CFR 890.5525 | K010031 |
| CHL | Carbon Dioxide Electrode, 275-001Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | Class 2 | 21 CFR 862.1120 | — |
| CEM | Chloride Electrode, REF 3918-006Electrode, Ion Specific, Potassium | Class 2 | 21 CFR 862.1600 | — |
| CEM | Carbon Dioxide Electrode, 275-001Electrode, Ion Specific, Potassium | Class 2 | 21 CFR 862.1600 | — |
and 25 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.