K071101 is an FDA 510(k) clearance for the TRU RSV. This device is classified as a Antisera, Cf, Poliovirus 1-3 (Class I - General Controls, product code GOG).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 18, 2007, 182 days after receiving the submission on April 19, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.
| 510(k) Number | K071101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2007 |
| Decision Date | October 18, 2007 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GOG — Antisera, Cf, Poliovirus 1-3 |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3405 |