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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Cpk Isoenzymes
510(k) Number K872598
Device Name MICROMI-CK(TM)
Applicant
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Applicant Contact SHAH, PHD
Correspondent
Intl. Immunoassay Laboratories, Inc.
1900 Wyatt Dr., #11
Santa Clara,  CA  95054
Correspondent Contact SHAH, PHD
Regulation Number862.1215
Classification Product Code
JHT  
Date Received07/02/1987
Decision Date 08/03/1987
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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