K890422 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) D-DIMER. This device is classified as a Fibrin Split Products (Class II - Special Controls, product code GHH).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 27, 1989, 60 days after receiving the submission on January 26, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7320.
| 510(k) Number | K890422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1989 |
| Decision Date | March 27, 1989 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GHH — Fibrin Split Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7320 |