K904329 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY. This device is classified as a Antigen, C. Difficile (Class I - General Controls, product code MCB).
Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on March 12, 1991, 173 days after receiving the submission on September 20, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K904329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1990 |
| Decision Date | March 12, 1991 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | MCB — Antigen, C. Difficile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |