MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE


Device Classification Name

device, specimen collection

510(k) Number K103805
Device Name MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
Applicant
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
potley lane
corsham, wiltshire, 

GB

sn13 9rt

Applicant Contact david ellis
Correspondent
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
potley lane
corsham, wiltshire, 

GB

sn13 9rt

Correspodent Contact david ellis
Regulation Number 866.2900
Classification Product Code
LIO  
Subsequent Product Code
JTW  
Date Received 12/28/2010
Decision Date 01/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No