K800656 is an FDA 510(k) clearance for the A-GENT QUANTICHROM THROMBIGEN-E. 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 May 30, 1980, 66 days after receiving the submission on March 25, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7720.
| 510(k) Number | K800656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1980 |
| Decision Date | May 30, 1980 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGQ — Test, Prothrombin Consumption |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7720 |