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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name U.V. Method, Cpk Isoenzymes
510(k) Number K912231
Device Name PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
Applicant
INTL. IMMUNOASSAY LABORATORIES, INC.
1900 WYATT DR., #11
SANTA CLARA,  CA  95054
Applicant Contact VIPIN D SHAH
Correspondent
INTL. IMMUNOASSAY LABORATORIES, INC.
1900 WYATT DR., #11
SANTA CLARA,  CA  95054
Correspondent Contact VIPIN D SHAH
Regulation Number862.1215
Classification Product Code
JHW  
Date Received05/20/1991
Decision Date 07/08/1991
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
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