K082472 is an FDA 510(k) clearance for the VIROCULT, MODEL MW950. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Medical Wire & Equipment Company (Bath), Ltd. (Corsham, Wiltshire, GB). The FDA issued a Cleared decision on December 30, 2008, 124 days after receiving the submission on August 28, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K082472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2008 |
| Decision Date | December 30, 2008 |
| Days to Decision | 124 days |
| Submission Type | Abbreviated |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIO - Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |