K972639 is an FDA 510(k) clearance for the TINA-QUANT HAPTOGLOBIN. This device is classified as a Haptoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DAD).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 9, 1998, 178 days after receiving the submission on July 15, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5460.
| 510(k) Number | K972639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1997 |
| Decision Date | January 09, 1998 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DAD — Haptoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5460 |