Microprotein Reagent Set
510(k) K921412
Microprotein Reagent Set is a Class II device made by Sterling Diagnostics Inc, cleared under FDA 510(k) K921412 on 21 Jan 1993, 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 | FDA 510(k)SESE | NumberK921412 | Date21 Jan 1993 | StatusActive |
Official records
- FDA 510(k) database K921412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CEK
- FDA applicant
- Sterling Diagnostics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1635
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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