K915829 is an FDA 510(k) clearance for the IL TEST(TM) HAPTOGLOBIN (HPT). This device is classified as a Haptoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DAD).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1992, 212 days after receiving the submission on December 30, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5460.
| 510(k) Number | K915829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1991 |
| Decision Date | July 29, 1992 |
| Days to Decision | 212 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 |