K960871 is an FDA 510(k) clearance for the SPECTROLYSE ANTITHROMBIN III (ANTI-XA). This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 14, 1996, 163 days after receiving the submission on March 4, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K960871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1996 |
| Decision Date | August 14, 1996 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |