K062546 is an FDA 510(k) clearance for the IMMUNOCARD STAT! EHEC, MODEL 751630. This device is classified as a Antigens, All Types, Escherichia Coli (Class I - General Controls, product code GMZ).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 14, 2007, 168 days after receiving the submission on August 30, 2006.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3255.
| 510(k) Number | K062546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2006 |
| Decision Date | February 14, 2007 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMZ — Antigens, All Types, Escherichia Coli |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3255 |