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Document NumberK911624
Test Name BRITISH-AMERICAN MEDICAL, INC., VISION BG TEST STRIPS  
Manufacturer NameBRITISH-AMERICAN MEDICAL, INC.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date07/17/1991
Device Classification Name glucose oxidase, glucose
510(k) Number K911624
Device Name VISION BG TEST STRIP
Applicant
BRITISH-AMERICAN MEDICAL, INC.
26941 CABOT ROAD, SUITE 115
LAGUNA HILLS,  CA  92653
Applicant Contact THOMAS L BUCKLEY
Correspondent
BRITISH-AMERICAN MEDICAL, INC.
26941 CABOT ROAD, SUITE 115
LAGUNA HILLS,  CA  92653
Correspondent Contact THOMAS L BUCKLEY
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/11/1991
Decision Date 07/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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