K913943 is an FDA 510(k) clearance for the SERIM DISINTEK REAGENT STRIPS. This device is classified as a Sterilant, Medical Devices (Class II — Special Controls, product code MED).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on March 26, 1992, 204 days after receiving the submission on September 4, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K913943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1991 |
| Decision Date | March 26, 1992 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6885 |