Quantex C4
by Instrumentation Laboratory CO
510(k) K962198
Quantex C4 is a Class II device made by Instrumentation Laboratory CO, cleared under FDA 510(k) K962198 on 26 Sep 1996, 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 | NumberK962198 | Date26 Sep 1996 | StatusActive |
Official records
- FDA 510(k) database K962198
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DBI
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5240
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
Similar devices
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- C4 by Abbott Laboratories
- IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 by Dako Corp.
- N-ASSAY TIA C4 TEST KIT by Crestat Diagnostics, Inc.
- COMPLEMENT C4 NEPHELOMETRIC ASSAY by Kallestad Laboratories, Inc.
- ARCHITECT 09D9724 by ABBOTT IRELAND
- SPQ Antibody Reagent Set II for C4 by Atlantic Antibodies
- Atellica CH C4 11097623 by Siemens Healthcare Diagnostics Inc.