K862763 is an FDA 510(k) clearance for the TINA-QUANT(R) IGA. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 4, 1986, 44 days after receiving the submission on July 22, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K862763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1986 |
| Decision Date | September 04, 1986 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |