K893608 is an FDA 510(k) clearance for the ACTICHROME ATIII KIT. This device is classified as a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ).
Submitted by American Diagnostic Corp. (New York, US). The FDA issued a Cleared decision on June 23, 1989, 44 days after receiving the submission on May 10, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K893608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1989 |
| Decision Date | June 23, 1989 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7060 |