K934894 is an FDA 510(k) clearance for the CULTURESWAB TRANSPORT SYSTEM. This device is classified as a System, Transport, Aerobic (Class I - General Controls, product code JTW).
Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on February 22, 1994, 140 days after receiving the submission on October 5, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K934894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTW — System, Transport, Aerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |