K943050 is an FDA 510(k) clearance for the MYCOAKT M KANSASII CULTURE ID KIT. This device is classified as a Kit, Identification, Mycobacteria (Class I - General Controls, product code JSY).
Submitted by Dynagen, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 13, 1995, 259 days after receiving the submission on June 27, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K943050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1994 |
| Decision Date | March 13, 1995 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JSY — Kit, Identification, Mycobacteria |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |