K990206 is an FDA 510(k) clearance for the SERIM BLOOD LEAK TEST STRIP. This device is classified as a Detector, Leak, Blood (Class II - Special Controls, product code FJD).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on April 21, 1999, 90 days after receiving the submission on January 21, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K990206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1999 |
| Decision Date | April 21, 1999 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJD — Detector, Leak, Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |