K851978 is an FDA 510(k) clearance for the LYFO-KWIK OMI KIT. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).
Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on June 4, 1985, 28 days after receiving the submission on May 7, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K851978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1985 |
| Decision Date | June 04, 1985 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSS — Kit, Identification, Enterobacteriaceae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |