Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 25
- Latest Decision
- 1977-06-24
Clearances · page 36 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K770962 | GOAT ANTISERUM IGA NEPHELOMETRIC | Kallestad Laboratories, Inc. | CZP | Class II | 1977-06-24 |
| K771064 | ANA TEST | Gull Laboratories, Inc. | DHN | Class II | 1977-06-24 |
| K770964 | GOAT ANTISERUM COMPLEMENT C3 NEPHEL. | Kallestad Laboratories, Inc. | DAK | Class II | 1977-06-24 |
| K770961 | GOAT ANTISERUM IGG NEPHELOMETRIC | Kallestad Laboratories, Inc. | DEW | Class II | 1977-06-24 |
| K770702 | IN VITRO FERRITIN RIA TEST | Clinical Assays, Inc. | DBF | Class II | 1977-06-17 |
| K770866 | RABBIT COMPLEMENT | Cedarlake Labs , Ltd. | DHL | Class I | 1977-06-03 |
| K770547 | LAS-R TM HUMAN COMPLEMENT C4 TEST | Hyland Therapeutic Div., Travenol Laboratories | DAK | Class II | 1977-05-03 |
| K770670 | FLOR. CONJUG. HUMAN FAB FRAGMENT | Kent Laboratories, Inc. | DFK | Class I | 1977-04-28 |
| K770669 | RHODAMINE-CONJUGATED ANTISERUM | Kent Laboratories, Inc. | DEW | Class II | 1977-04-28 |
| K770597 | DASP TM ANTI-RABBIT | Organon, Inc. | DEW | Class II | 1977-04-28 |
| K770668 | FLUORESCEIN CONJUGATED ANTISERUM | Kent Laboratories, Inc. | DEW | Class II | 1977-04-28 |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Kallestad Laboratories, Inc. | JZS | Class I | 1977-04-27 |
| K770719 | IMMUNOELECTROFILM KIH | Kallestad Laboratories, Inc. | JZS | Class I | 1977-04-26 |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Kallestad Laboratories, Inc. | JZS | Class I | 1977-04-26 |
| K770662 | VIEWER, FLUOROMETIC, MODEL 721 | Corning Medical & Scientific | JZT | Class I | 1977-04-15 |
| K770548 | IMMUNOPLATE III RADIO IMMUNODIFFUSION | Hyland Therapeutic Div., Travenol Laboratories | JZQ | Class I | 1977-04-15 |
| K761224 | ULTRA LOW LEVEL IMMUNOGLOBULIN G | Intl. Diagnostic Technology | DEW | Class II | 1977-04-07 |
| K761225 | LOW LEVEL HUMAN ALBUMIN TEST KITS | Intl. Diagnostic Technology | DCF | Class II | 1977-04-07 |
| K770057 | NDNA IMMUNOPATH FLUORO-KIT | Clinical Sciences, Inc. | DHN | Class II | 1977-04-05 |
| K770484 | FLUOR. CONJUGATED ANTISERUM | Kent Laboratories, Inc. | DEW | Class II | 1977-03-21 |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | JZS | Class I | 1977-02-01 |
| K761270 | IMMUNO-TEC II OT AGAROSE PLATE KIT | Behring Diagnostics, Inc. | JZP | Class I | 1976-12-30 |
| K761236 | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Behring Diagnostics, Inc. | JZW | Class I | 1976-12-30 |
| K761235 | LASER STANDARD SERUM | Behring Diagnostics, Inc. | JZW | Class I | 1976-12-30 |
| K760917 | LAS-R HUMAN HAPTOGLOBIN TEST | Hyland Therapeutic Div., Travenol Laboratories | DFT | Class II | 1976-12-30 |
| K761311 | ACCRAASSAY RID KITS | Miles Laboratories, Inc. | JZQ | Class I | 1976-12-30 |
| K760673 | RAPI/TEX-LGM KIT | Hoechst-Roussel Pharmaceuticals, Inc. | DFT | Class II | 1976-12-19 |
| K761156 | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | DAS | Class I | 1976-12-09 |
| K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST | Hyland Therapeutic Div., Travenol Laboratories | DEM | Class II | 1976-11-16 |
| K760681 | INDIRECT FLUORESCENT (IFA-ANA) | Wampole Laboratories | DHN | Class II | 1976-10-21 |
| K760354 | TEST, SLIDE FOR C-REATIVE PROTEIN | Icl Scientific | DCK | Class II | 1976-08-11 |
| K760034 | TEST, STREP, LATEX SLIDE | Gamma Biologicals, Inc. | DEM | Class II | 1976-08-11 |
| K760043 | TEST, RHEUM. ARTH., CARD (MACRO-VUE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | DHR | Class II | 1976-08-03 |
| K760040 | TEST, MONO., CARD (MACRO-VUE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | KTN | Class II | 1976-08-03 |
| K760206 | TEST, DETECTION, ANTINUCLEAR ANTIBODIES | Intl. Diagnostic Technology | DHN | Class II | 1976-08-03 |
| K760036 | TEST, LATEX SLIDE, RHEUMATOID FACTOR | Gamma Biologicals, Inc. | DHR | Class II | 1976-08-03 |
| K760035 | TEST, C-REATIVE PROTEIN, LATEX SLIDE | Gamma Biologicals, Inc. | DCK | Class II | 1976-08-03 |
| K760209 | ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP | Zeus Scientific, Inc. | DHN | Class II | 1976-07-26 |
| K760148 | SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN | Oxford Laboratories, Inc. | CZW | Class II | 1976-07-20 |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | CZP | Class II | 1976-07-20 |
| K760153 | TEST, (IVDP) ANTINUCLEAR ANTIBODY | Zeus Scientific, Inc. | DHN | Class II | 1976-07-20 |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | DEX | Class I | 1976-07-20 |
| K760154 | TEST, (IVDP) THYROID ANTIBODY | Zeus Scientific, Inc. | JZO | Class II | 1976-07-20 |
| K760155 | TEST, (IVDP) MITOCHONDRIAL ANTIBODY | Zeus Scientific, Inc. | DBM | Class II | 1976-07-20 |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | DBE | Class II | 1976-07-20 |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | DAD | Class II | 1976-07-20 |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | Oxford Laboratories, Inc. | DFT | Class II | 1976-07-20 |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | DEW | Class II | 1976-07-19 |
3,548 clearances in the Immunology panel. Data: openFDA.