510(k) K103805

MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE by Medical Wire & Equipment Company (Bath), Ltd. — Product Code LIO

K103805 is an FDA 510(k) premarket notification submitted by Medical Wire & Equipment Company (Bath), Ltd. for the device "MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE". The FDA issued a decision of Substantially Equivalent on January 25, 2011. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Medical Wire & Equipment Company (Bath), Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2011
Date Received
December 28, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type