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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K903441
Device Name MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
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
JHX  
Date Received07/31/1990
Decision Date 11/06/1990
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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