K930157 is an FDA 510(k) clearance for the TEST THROMBIN. This device is classified as a Test, Thrombin Time (Class II - Special Controls, product code GJA).
Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on May 14, 1993, 121 days after receiving the submission on January 13, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7875.
| 510(k) Number | K930157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1993 |
| Decision Date | May 14, 1993 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJA — Test, Thrombin Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7875 |