Panels › Immunology › Product code DAK · Class 2
Complement C1q, Antigen, Antiserum, Control
Regulation 866.5240
0510(k)s in 12 months (28 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DAK
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Diagnostic Systems, Inc. | 3 | 0 |
| The Binding Site, Ltd. | 2 | 0 |
| Biostar Medical Products, Inc. | 2 | 0 |
| Cytotech, Inc. | 2 | 0 |
| Diagnostic Hybrids, Inc. | 0 | 2 |
| Gamma Medical Products, Inc. | 2 | 0 |
| Hyland Therapeutic Div., Travenol Laboratories | 2 | 0 |
| Icl Scientific | 2 | 0 |
| American Laboratory Products Co., Ltd. | 1 | 0 |
| Collaborative Research, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2003 | K031563 | BINDAZYME CLQ CIC EIA KIT The Binding Site, Ltd. | DAK |
| Aug 29, 2003 | K032254 | IBL C1Q-CIC CIA TEST Ibl GmbH | DAK |
| Jan 29, 2002 | K012576 | CIC-C1Q EIA American Laboratory Products Co., Ltd. | DAK |
| Sep 30, 1998 | K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES Sangstat Medical Corp. | DAK |
| Mar 17, 1998 | K972873 | IMMUSTRIP HAMA IGG Immunomedics, Inc. | DAK |
| May 30, 1995 | K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. | DAK |
| Oct 28, 1991 | K914388 | C1 RID KIT The Binding Site, Ltd. | DAK |
| Aug 4, 1988 | K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS Cytotech, Inc. | DAK |
| Mar 30, 1987 | K860996 | SANASSAY IC TEST Scientific Sales Intl., Inc. | DAK |
| Jan 9, 1987 | K864312 | IC MICROASSAY Diamedix Corp. | DAK |
| Sep 4, 1986 | K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY Cytotech, Inc. | DAK |
| Jun 20, 1986 | K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT Biostar Medical Products, Inc. | DAK |
| Dec 16, 1985 | K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT Biostar Medical Products, Inc. | DAK |
| Apr 29, 1985 | K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL Gilford | DAK |
| Feb 4, 1985 | K844294 | CORDIA IC Cordis Corp. | DAK |
| Jun 22, 1984 | K833275 | GMP CIQ ELISA TEST KIT Gamma Medical Products, Inc. | DAK |
| Jun 13, 1984 | K833636 | ORTHO* SERUM ELISA TEST SYSTEM Ortho Diagnostic Systems, Inc. | DAK |
| Jun 1, 1984 | K841541 | SERUM COMPLEMENT ACTIVITY TEST-SCAT Collaborative Research, Inc. | DAK |
| Nov 5, 1982 | K823009 | GAMMA CLQ Gamma Medical Products, Inc. | DAK |
| Aug 27, 1982 | K821949 | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST Ortho Diagnostic Systems, Inc. | DAK |
| Jun 25, 1982 | K821806 | ORTHO CLG IMMUNE COMPLEX TEST SYSTEM Ortho Diagnostic Systems, Inc. | DAK |
| Dec 27, 1979 | K792472 | ELECTRO-IMMUNO-QUANTITATION (EIQ) Icl Scientific | DAK |
| Aug 14, 1978 | K781022 | ANTI-HUMAN CIQ SERUM Icl Scientific | DAK |
| May 18, 1978 | K780729 | LAS-R HUMAN COMPLEMENT CLQ TEST Hyland Therapeutic Div., Travenol Laboratories | DAK |
| Nov 30, 1977 | K772114 | FIAX C4 ASSAY Idt, A Division of Whittaker M.A. Bioproducts | DAK |
| Nov 3, 1977 | K772003 | HUMAN REFERENCE SERUM C4 COMPLEMENT G.D. Searle and Co. | DAK |
| Jun 24, 1977 | K770964 | GOAT ANTISERUM COMPLEMENT C3 NEPHEL. Kallestad Laboratories, Inc. | DAK |
| May 3, 1977 | K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST Hyland Therapeutic Div., Travenol Laboratories | DAK |
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