K870930 is an FDA 510(k) clearance for the TINA-QUANT(R) (A) C3. This device is classified as a Iga, Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code CZM).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 24, 1987, 15 days after receiving the submission on March 9, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K870930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1987 |
| Decision Date | March 24, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CZM — Iga, Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |