K903638 is an FDA 510(k) clearance for the GASTRO-INTESTINAL ACCU-CULSHURE TM. This device is classified as a Device, Specimen Collection (Class I — General Controls, product code LIO).
Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on January 18, 1991, 158 days after receiving the submission on August 13, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K903638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1990 |
| Decision Date | January 18, 1991 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2900 |