DAD — Haptoglobin, Antigen, Antiserum, Control Class II
FDA product code DAD covers "Haptoglobin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5460. Submissions are reviewed by the Immunology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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 |