K860658 is an FDA 510(k) clearance for the KULTSURE (CATALOGUE NO. M250). This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on March 4, 1986, 11 days after receiving the submission on February 21, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K860658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1986 |
| Decision Date | March 04, 1986 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |