K882637 is an FDA 510(k) clearance for the ACCU-CULSHURE TM. This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).
Submitted by Accu-Med Corp. (Pleasantville, US). The FDA issued a Cleared decision on July 6, 1988, 9 days after receiving the submission on June 27, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K882637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1988 |
| Decision Date | July 06, 1988 |
| Days to Decision | 9 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 |