K945488 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK. This device is classified as a Kit, Anaerobic Identification (Class I - General Controls, product code JSP).
Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on May 11, 1995, 184 days after receiving the submission on November 8, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K945488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1994 |
| Decision Date | May 11, 1995 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JSP — Kit, Anaerobic Identification |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |