FDA Product Code
FDA Product Code DAD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5460
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993480 | K-ASSAY HAPTOGLOBIN | Kamiya Biomedical Co. | 1999-11-24 | Traditional | PDF ↗ |
| K972639 | TINA-QUANT HAPTOGLOBIN | Boehringer Mannheim Corp. | 1998-01-09 | Traditional | PDF ↗ |
| K964301 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K963286 | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | Beckman Instruments, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K952593 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K915829 | IL TEST(TM) HAPTOGLOBIN (HPT) | Instrumentation Laboratory CO | 1992-07-29 | Traditional | PDF ↗ |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | Reagents Applications, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Atlantic Antibodies | 1989-02-22 | Traditional | PDF ↗ |
| K873866 | HAPTOGLOBIN | Unipath , Ltd. | 1987-10-20 | Traditional | PDF ↗ |
| K872717 | QM300 HAPTOGLOBIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | Cooper Biomedical, Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | Applications Lab | 1985-03-05 | Traditional | PDF ↗ |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Tago, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K831957 | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB | Kent Laboratories, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K812494 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K801433 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-08 | Traditional | PDF ↗ |
| K772245 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DAD · Class II · Immunology. Data: openFDA.