K862388 is an FDA 510(k) clearance for the BIOTIS TCBS AGAR. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).
Submitted by Otisville Biotech, Inc. (Otisville, US). The FDA issued a Cleared decision on July 3, 1986, 9 days after receiving the submission on June 24, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K862388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1986 |
| Decision Date | July 03, 1986 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |