DAD — Haptoglobin, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DAD
- Device Class
- Class II
- Regulation Number
- 866.5460
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K993480 | kamiya biomedical | K-ASSAY HAPTOGLOBIN | November 24, 1999 |
| K972639 | boehringer mannheim | TINA-QUANT HAPTOGLOBIN | January 9, 1998 |
| K964301 | crestat diagnostics | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K963286 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | October 7, 1996 |
| K952593 | behring diagnostics | N/T PROTEIN CONTROL SY/L, M AND H | July 17, 1995 |
| K915829 | instrumentation laboratory | IL TEST(TM) HAPTOGLOBIN (HPT) | July 29, 1992 |
| K911898 | reagents applications | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | May 8, 1991 |
| K890562 | atlantic antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | February 22, 1989 |
| K873866 | unipath | HAPTOGLOBIN | October 20, 1987 |
| K872717 | kallestad diag, a div. of erbamont | QM300 HAPTOGLOBIN ANTIBODY PACK | July 21, 1987 |
| K864512 | cooper biomedical | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | February 13, 1987 |
| K850584 | applications lab | SPQ TEST SYSTEM FOR HAPTOGLOBIN | March 5, 1985 |
| K840404 | tago | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | March 9, 1984 |
| K831957 | kent laboratories | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB | July 18, 1983 |
| K812494 | dako | IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO | September 23, 1981 |
| K801433 | j.t. baker chemical | HAPTOGLOBIN NEPHELOMETRIC ASSAY | July 8, 1980 |
| K772245 | kallestad laboratories | HAPTOGLOBIN NEPHELOMETRIC ASSAY | December 22, 1977 |
| K760144 | oxford laboratories | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | July 20, 1976 |