K800725 is an FDA 510(k) clearance for the A-GENT QUANTICHROM THROMBIGEN I. This device is classified as a Test, Time, Partial Thromboplastin (Class II - Special Controls, product code GGW).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 4, 1980, 64 days after receiving the submission on April 1, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K800725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1980 |
| Decision Date | June 04, 1980 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGW — Test, Time, Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |