K935618 is an FDA 510(k) clearance for the SPECIMEN TRANSPORT MEDIUM. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 21, 1994, 150 days after receiving the submission on November 22, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K935618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1993 |
| Decision Date | April 21, 1994 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |