Bi-Level Quality Control Kit 2814
by Medica Corp.
Bi-Level Quality Control Kit 2814 is a Class II device made by Medica Corp., cleared under FDA 510(k) K864872 on 13 Mar 1987 and listed in FDA GUDID since 4 Dec 2018 (UDI-DI 00386100003272), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00386100003272 | Date4 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK864872 | Date13 Mar 1987 | StatusActive |
Official records
- AccessGUDID record 00386100003272
- FDA 510(k) database K864872
Across registries
- FDA 510(k) K864872 decided 13 Mar 1987 Active
- FDA GUDID UDI-DI 00386100003272 listed 4 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K864872
- Listed FDA GUDID 00386100003272
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bi-Level Quality Control Kit
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
- Model / Ref / Catalog
- 2814
- Primary DI / UDI-DI
- 00386100003272
- 510(k) Number
- FDA product code
- CEM, JGS
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
- Device class
- Class II
- Regulation number
- 862.1600, 862.1665
- GUDID distribution status
- In Commercial Distribution
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