FDA Product Code
FDA Product Code DBA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5250
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141100 | OPTILITE C1 INACTIVATOR KIT | The Binding Site Group , Ltd. | 2014-07-18 | Traditional | PDF ↗ |
| K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-04-15 | Traditional | PDF ↗ |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dade Behring, Inc. | 2007-12-21 | Traditional | PDF ↗ |
| K011780 | K-ASSAY C1-INA | Kamiya Biomedical Co. | 2001-07-25 | Traditional | PDF ↗ |
| K003747 | C1-INHIBITOR MICROTITER ASSAY DEVICE | Baxter Healthcare Corp | 2001-03-19 | Traditional | PDF ↗ |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Behring Diagnostics, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K915431 | COMPLEMENT C1 INACTIVATOR KIT | The Binding Site, Ltd. | 1992-01-17 | Traditional | PDF ↗ |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-07-23 | Traditional | PDF ↗ |
| K821898 | ORTHO CLASSICAL PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | 1982-07-16 | Traditional | PDF ↗ |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | Icl Scientific | 1978-08-14 | Traditional | PDF ↗ |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-22 | Traditional | PDF ↗ |
Product code DBA · Class II · Immunology. Data: openFDA.