K901645 is an FDA 510(k) clearance for the ANAEROBIC ACCU-CULSHURE(TM). This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).
Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on July 16, 1990, 98 days after receiving the submission on April 9, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K901645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1990 |
| Decision Date | July 16, 1990 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTX — Transport Systems, Anaerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |