Product code DAK
- Device name
- Complement C1q, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5240
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031563 | BINDAZYME CLQ CIC EIA KIT | The Binding Site, Ltd. | 2003-09-10 |
| K032254 | IBL C1Q-CIC CIA TEST | Ibl GmbH | 2003-08-29 |
| K012576 | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | 2002-01-29 |
| K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | Sangstat Medical Corp. | 1998-09-30 |
| K972873 | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | 1998-03-17 |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 |
| K914388 | C1 RID KIT | The Binding Site, Ltd. | 1991-10-28 |
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | 1988-08-04 |
| K860996 | SANASSAY IC TEST | Scientific Sales Intl., Inc. | 1987-03-30 |
| K864312 | IC MICROASSAY | Diamedix Corp. | 1987-01-09 |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-09-04 |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1986-06-20 |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1985-12-16 |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Gilford | 1985-04-29 |
| K844294 | CORDIA IC | Cordis Corp. | 1985-02-04 |
| K833275 | GMP CIQ ELISA TEST KIT | Gamma Medical Products, Inc. | 1984-06-22 |
| K833636 | ORTHO* SERUM ELISA TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1984-06-13 |
| K841541 | SERUM COMPLEMENT ACTIVITY TEST-SCAT | Collaborative Research, Inc. | 1984-06-01 |
| K823009 | GAMMA CLQ | Gamma Medical Products, Inc. | 1982-11-05 |
| K821949 | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | 1982-08-27 |
| K821806 | ORTHO CLG IMMUNE COMPLEX TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1982-06-25 |
| K792472 | ELECTRO-IMMUNO-QUANTITATION (EIQ) | Icl Scientific | 1979-12-27 |
| K781022 | ANTI-HUMAN CIQ SERUM | Icl Scientific | 1978-08-14 |
| K780729 | LAS-R HUMAN COMPLEMENT CLQ TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-05-18 |
| K772114 | FIAX C4 ASSAY | Idt, A Division of Whittaker M.A. Bioproducts | 1977-11-30 |
| K772003 | HUMAN REFERENCE SERUM C4 COMPLEMENT | G.D. Searle and Co. | 1977-11-03 |
| K770964 | GOAT ANTISERUM COMPLEMENT C3 NEPHEL. | Kallestad Laboratories, Inc. | 1977-06-24 |
| K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426950514190 | QUANTA Lite® C1q CIC ELISA | INOVA DIAGNOSTICS, INC. | 2026-04-20 |
| B1761110 | Antiserum to Human C1q | KENT LABORATORIES INC | 2016-09-24 |
| B1761112 | Anti Human Complement C1q FITC | KENT LABORATORIES INC | 2016-09-24 |
| 05051700010511 | Human Complement C1q BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00813545023737 | Scanlisa C1q Elisa 96 Test | SCIMEDX CORPORATION | 2016-09-20 |
| 00813545023744 | C1q Plates & Calibrator Sets | SCIMEDX CORPORATION | 2016-09-20 |
| 30014613335535 | MicroVue | QUIDEL CORPORATION | 2016-09-15 |
| 30014613335559 | MicroVue | QUIDEL CORPORATION | 2016-09-15 |
| EBUHEKCIC1 | CIC-C1q ELISA Kit | Bühlmann Laboratories AG | 2016-09-01 |