K041445 is an FDA 510(k) clearance for the IMMUNOCARD STAT! RSV MODEL #750630. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 13, 2004, 73 days after receiving the submission on June 1, 2004.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K041445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2004 |
| Decision Date | August 13, 2004 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |