K864243 is an FDA 510(k) clearance for the MACCONKEY AGAR. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).
Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987, 154 days after receiving the submission on October 28, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K864243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1986 |
| Decision Date | March 31, 1987 |
| Days to Decision | 154 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 |