FDA Product Code
FDA Product Code DCK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5270
510(k) Clearances — 126 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K863628 | C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS | Technicon Instruments Corp. | 1986-10-15 | Traditional | PDF ↗ |
| K863329 | ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863328 | ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K860549 | DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-06-10 | Traditional | PDF ↗ |
| K860550 | DU PONT C-REACTIVE PROTEIN (CRP) ASSAY | E.I. Dupont DE Nemours & Co., Inc. | 1986-06-10 | Traditional | PDF ↗ |
| K854542 | TDX C-REACTIVE PROTEIN | Abbott Laboratories | 1986-01-24 | Traditional | PDF ↗ |
| K854221 | DIESSE CRP TEST KIT | Marvic Interpharma, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K851842 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | Atlantic Antibodies | 1985-06-05 | Traditional | PDF ↗ |
| K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT | Fisher Diagnostics | 1985-04-19 | Traditional | PDF ↗ |
| K850590 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | Applications Lab | 1985-03-01 | Traditional | PDF ↗ |
| K841862 | IMMU-TEC | Medilab Corp. | 1984-06-13 | Traditional | PDF ↗ |
| K832054 | FIAX CRP TEST KIT | Intl. Diagnostic Technology | 1983-08-26 | Traditional | PDF ↗ |
| K831958 | RADIAL IMMUNO-TEST FOR HUMAN C-REACTI | Kent Laboratories, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K823417 | PRISMA-C-REACTIVE PROTEIN CALIBRATORS | Syva Co. | 1982-12-09 | Traditional | PDF ↗ |
| K823416 | PRISMA C-REACTIVE PROTEIN ASSAY | Syva Co. | 1982-12-09 | Traditional | PDF ↗ |
| K823415 | PRISMA C-REACTIVE PROTEIN CONTROLS | Syva Co. | 1982-12-09 | Traditional | PDF ↗ |
| K822067 | EMIT C-REACTIVE PROTEIN AUTOCAROUSEL | Syva Co. | 1982-07-27 | Traditional | PDF ↗ |
| K821412 | C-REACTIVE PROTEIN CONTROL | Syva Co. | 1982-07-22 | Traditional | PDF ↗ |
| K821984 | QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. | Kallestad Laboratories, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K811617 | QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. | Kallestad Laboratories, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K791461 | AGGLUTINOTEST-C-REACTIVE PROTEIN | Volu Sol Medical Industries | 1979-12-31 | Traditional | PDF ↗ |
| K792238 | CRPTELL | Central Biological Co. | 1979-11-30 | Traditional | PDF ↗ |
| K791560 | GOAT ANTI-HUMAN C-REACTIVE PROTEIN | Protos Laboratories | 1979-09-24 | Traditional | PDF ↗ |
| K791650 | HUMAN, C-REACTIVE PROTEIN (CRP) | Beckman Instruments, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K760354 | TEST, SLIDE FOR C-REATIVE PROTEIN | Icl Scientific | 1976-08-11 | Traditional | PDF ↗ |
| K760035 | TEST, C-REATIVE PROTEIN, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-03 | Traditional | PDF ↗ |
Product code DCK · Class II · Immunology. Data: openFDA.