K041003 is an FDA 510(k) clearance for the IMMUNOCARD TOXINS A & B, MODEL 712050. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 20, 2004, 123 days after receiving the submission on April 19, 2004.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K041003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2004 |
| Decision Date | August 20, 2004 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LLH — Reagents, Clostridium Difficile Toxin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |