K940472 is an FDA 510(k) clearance for the COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY. This device is classified as a Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (Class I - General Controls, product code GNM).
Submitted by Chemicon Intl., Inc. (Temecula, US). The FDA issued a Cleared decision on September 8, 1995, 583 days after receiving the submission on February 2, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3145.
| 510(k) Number | K940472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1994 |
| Decision Date | September 08, 1995 |
| Days to Decision | 583 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GNM — Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3145 |