K980185 is an FDA 510(k) clearance for the COLORPAC TOXIN A. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on July 17, 1998, 178 days after receiving the submission on January 20, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K980185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1998 |
| Decision Date | July 17, 1998 |
| Days to Decision | 178 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 |