Identity
- Trade Name
- Clinitek Atlas® Calibration Kit FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System. FDA UDI
- Model / Reference
- 10311123 FDA UDI
- Description
- Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System. FDA UDI
Identifiers
- Catalog Number
- 5018A FDA UDI
- Primary DI / UDI-DI
- 00630414373027 FDA UDI
- 510(k) Number
- K932674 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple urine analyte IVD, control
Clinitek Atlas® Calibration Kit by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, control.
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- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
- ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
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Cleared under the same submission
K932674 also covers:
- CLINITEK Atlas® Control+ Strips — Siemens Healthcare Diagnostics
- CLINITEK Atlas® Control- Strips. — Siemens Healthcare Diagnostics
- Clinitek Atlas® 10 Reagent PAK for Urine Chemistry — Siemens Healthcare Diagnostics
- Clinitek Atlas® Calibrator #4 — Siemens Healthcare Diagnostics
- Clinitek Atlas® Rinse Additiive — Siemens Healthcare Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI f805bd9f-571a-4c23-b8f4-8f65affbe17e 37 fields · synced May 30, 2026