Ez Complement C4
510(k) K892129
Ez Complement C4 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K892129 on 14 Apr 1989, active as of 10 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 | NumberK892129 | Date14 Apr 1989 | StatusActive |
Official records
- FDA 510(k) database K892129
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- Withdrawn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
Other devices filed under FDA product code DBI (Complement C4, Antigen, Antiserum, Control).
- QUANTEX C4 by INSTRUMENTATION LABORATORY COMPANY
- DIMENSION C4 FLEX REAGENT CARTRIDGE by Dade Behring, Inc.
- COMPLEMENT C4 NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co.
- PLATES FOR HUMAN C4 COMPLEMENT by G.D. Searle and Co.
- TINA-QUANT COMPLEMENT C4 TEST SYSTEM by Roche Diagnostics Corp.
- Dimension® Flex® reagent cartridge C4 10444981 DF102 by Siemens Healthcare Diagnostics Inc.
- RAICHEM SPIA C4 REAGENT by Reagents Applications, Inc.
- TINA-QUANT(R) (A) C4 by Boehringer Mannheim Corp.
- GILFORD C4 COMPLEMENT REAGENT by Gilford
- GOAT ANTI-HUMAN COMPLEMENT C4 by Protos Laboratories