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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K911141
Device Name HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
Applicant
Hemocue, Inc.
C/O Robert Joel Slomof
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R. J SLOMOFF
Correspondent
Hemocue, Inc.
C/O Robert Joel Slomof
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R. J SLOMOFF
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/14/1991
Decision Date 05/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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