K012768 is an FDA 510(k) clearance for the HEMOSIL RECOMBI PLASTIN. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 18, 2001, 32 days after receiving the submission on August 17, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K012768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2001 |
| Decision Date | September 18, 2001 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS — Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |