K021190 is an FDA 510(k) clearance for the PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 25, 2002, 193 days after receiving the submission on April 15, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K021190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2002 |
| Decision Date | October 25, 2002 |
| Days to Decision | 193 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 |