FDA Product Code
FDA Product Code DBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5240
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100455 | SPAPLUS ANALYZER | The Binding Site | 2010-09-03 | Traditional | PDF ↗ |
| K012359 | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 | Traditional | PDF ↗ |
| K010325 | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K000468 | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | 2000-03-27 | Traditional | PDF ↗ |
| K994293 | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K981785 | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 | Traditional | PDF ↗ |
| K993481 | K-ASSAY C4 | Kamiya Biomedical Co. | 1999-11-29 | Traditional | PDF ↗ |
| K983356 | C4 | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K964300 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964297 | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K962582 | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962198 | QUANTEX C4 | Instrumentation Laboratory CO | 1996-09-26 | Traditional | PDF ↗ |
| K920010 | IL TEST COMPLEMENT 4 | Instrumentation Laboratory CO | 1992-03-13 | Traditional | PDF ↗ |
| K911899 | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | 1991-05-09 | Traditional | PDF ↗ |
| K892129 | EZ COMPLEMENT C4 | Diamedix Corp. | 1989-04-14 | Traditional | PDF ↗ |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | 1989-02-17 | Traditional | PDF ↗ |
| K882621 | COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 | Traditional | PDF ↗ |
| K872599 | QM300 C4 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-23 | Traditional | PDF ↗ |
| K871023 | PRECIMAT(R) C4 | Boehringer Mannheim Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K870931 | TINA-QUANT(R) (A) C4 | Boehringer Mannheim Corp. | 1987-03-24 | Traditional | PDF ↗ |
| K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853468 | GILFORD C4 COMPLEMENT REAGENT | Gilford | 1985-09-16 | Traditional | PDF ↗ |
| K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 | Applications Lab | 1985-03-01 | Traditional | PDF ↗ |
| K834605 | C4 ANTIGEN ANTIBODY CONTROL | Technicon Instruments Corp. | 1984-01-24 | Traditional | PDF ↗ |
| K831906 | RABBIT ANTISERUM TO HUMAN C4 | Dako Corp. | 1983-07-19 | Traditional | PDF ↗ |
| K830669 | FIAX COMPLEMENT C4 TEST KIT | Intl. Diagnostic Technology | 1983-04-08 | Traditional | PDF ↗ |
| K812490 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K810502 | SCRIPPSYSTEM C4 RID KIT | Scripps-Miles, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K802196 | GOAT ANTI-HUMAN COMPLEMENT C4 | Protos Laboratories | 1980-10-31 | Traditional | PDF ↗ |
| K801361 | COMPLEMENT C4 NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-06-30 | Traditional | PDF ↗ |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | Gelman Instrument Co. | 1978-02-03 | Traditional | PDF ↗ |
| K772247 | COMPLEMENT C4 NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K772004 | HUMAN C4 COMPLEMENT CONTROL SERUM | G.D. Searle and Co. | 1977-11-03 | Traditional | PDF ↗ |
| K772002 | PLATES FOR HUMAN C4 COMPLEMENT | G.D. Searle and Co. | 1977-11-02 | Traditional | PDF ↗ |
Product code DBI · Class II · Immunology. Data: openFDA.