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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 K881351
Device Name IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
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 Received03/30/1988
Decision Date 06/01/1988
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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