K103805 is an FDA 510(k) clearance for the MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE. 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 January 25, 2011, 28 days after receiving the submission on December 28, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K103805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2010 |
| Decision Date | January 25, 2011 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |