Quantimetrix Serum Enzyme Control
510(k) K880701
Quantimetrix Serum Enzyme Control is a Class I device made by Quantimetrix Corp., cleared under FDA 510(k) K880701 on 24 Mar 1988, active as of 12 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 | NumberK880701 | Date24 Mar 1988 | StatusActive |
Official records
- FDA 510(k) database K880701
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJT
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)).
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