K860194 is an FDA 510(k) clearance for the AUSTIN ENTERIC SYSTEM. This device is classified as a Culture Media, Multiple Biochemical Test (Class I - General Controls, product code JSE).
Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on February 20, 1986, 29 days after receiving the submission on January 22, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.
| 510(k) Number | K860194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1986 |
| Decision Date | February 20, 1986 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSE — Culture Media, Multiple Biochemical Test |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2320 |