K803081 is an FDA 510(k) clearance for the QUANTICHECK CONTROL PLASMA. This device is classified as a Test, Prothrombin Consumption (Class II - Special Controls, product code GGQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 17, 1981, 102 days after receiving the submission on December 5, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7720.
| 510(k) Number | K803081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1980 |
| Decision Date | March 17, 1981 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GGQ — Test, Prothrombin Consumption |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7720 |