K936034 is an FDA 510(k) clearance for the SERIM PYLORITEK REAGENT STRIPS. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on April 21, 1994, 127 days after receiving the submission on December 15, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K936034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1993 |
| Decision Date | April 21, 1994 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |