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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K874545
Device Name IMACK-MB TEST PROCEDURE (MODIFICATION)
Applicant
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Applicant Contact SHAH, PH.D.
Correspondent
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Correspondent Contact SHAH, PH.D.
Regulation Number862.1215
Classification Product Code
JHY  
Date Received11/03/1987
Decision Date 12/18/1987
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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