FDA Product Code
FDA Product Code DAK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5240
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031563 | BINDAZYME CLQ CIC EIA KIT | The Binding Site, Ltd. | 2003-09-10 | Traditional | PDF ↗ |
| K032254 | IBL C1Q-CIC CIA TEST | Ibl GmbH | 2003-08-29 | Traditional | PDF ↗ |
| K012576 | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | 2002-01-29 | Traditional | PDF ↗ |
| K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | Sangstat Medical Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K972873 | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | 1998-03-17 | Traditional | PDF ↗ |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K914388 | C1 RID KIT | The Binding Site, Ltd. | 1991-10-28 | Traditional | PDF ↗ |
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K860996 | SANASSAY IC TEST | Scientific Sales Intl., Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K864312 | IC MICROASSAY | Diamedix Corp. | 1987-01-09 | Traditional | PDF ↗ |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1986-06-20 | Traditional | PDF ↗ |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1985-12-16 | Traditional | PDF ↗ |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Gilford | 1985-04-29 | Traditional | PDF ↗ |
| K844294 | CORDIA IC | Cordis Corp. | 1985-02-04 | Traditional | PDF ↗ |
| K833275 | GMP CIQ ELISA TEST KIT | Gamma Medical Products, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K833636 | ORTHO* SERUM ELISA TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1984-06-13 | Traditional | PDF ↗ |
| K841541 | SERUM COMPLEMENT ACTIVITY TEST-SCAT | Collaborative Research, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K823009 | GAMMA CLQ | Gamma Medical Products, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K821949 | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | 1982-08-27 | Traditional | PDF ↗ |
| K821806 | ORTHO CLG IMMUNE COMPLEX TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K792472 | ELECTRO-IMMUNO-QUANTITATION (EIQ) | Icl Scientific | 1979-12-27 | Traditional | PDF ↗ |
| K781022 | ANTI-HUMAN CIQ SERUM | Icl Scientific | 1978-08-14 | Traditional | PDF ↗ |
| K780729 | LAS-R HUMAN COMPLEMENT CLQ TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-05-18 | Traditional | PDF ↗ |
| K772114 | FIAX C4 ASSAY | Idt, A Division of Whittaker M.A. Bioproducts | 1977-11-30 | Traditional | PDF ↗ |
| K772003 | HUMAN REFERENCE SERUM C4 COMPLEMENT | G.D. Searle and Co. | 1977-11-03 | Traditional | PDF ↗ |
| K770964 | GOAT ANTISERUM COMPLEMENT C3 NEPHEL. | Kallestad Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-05-03 | Traditional | PDF ↗ |
Product code DAK · Class II · Immunology. Data: openFDA.