JAS Diagnostics MICS-10
JAS Diagnostics MICS-10 is a Class II device made by Drew Scientific, Ltd., cleared under FDA 510(k) K070757 on 4 Dec 2007 and listed in FDA GUDID since 3 Oct 2018 (UDI-DI 00817274022825), active as of 22 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 | Number00817274022825 | Date3 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070757 | Date4 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 00817274022825
- FDA 510(k) database K070757
Across registries
- FDA 510(k) K070757 decided 4 Dec 2007 Active
- FDA GUDID UDI-DI 00817274022825 listed 3 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K070757
- Listed FDA GUDID 00817274022825
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- JAS Diagnostics
- Generic name
- Total microprotein IVD, calibrator
- Model / Ref / Catalog
- MICS-10
- Primary DI / UDI-DI
- 00817274022825
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Total microprotein IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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