K921618 is an FDA 510(k) clearance for the COXSACKIE VIRUS B1-B6 CF ANTIGENS. This device is classified as a Antigens, Cf (including Cf Control), Coxsackievirus A 1-24, B 1-6 (Class I - General Controls, product code GNG).
Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on June 29, 1992, 84 days after receiving the submission on April 6, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3145.
| 510(k) Number | K921618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1992 |
| Decision Date | June 29, 1992 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GNG — Antigens, Cf (including Cf Control), Coxsackievirus A 1-24, B 1-6 |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3145 |