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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 K901450
Device Name MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
Original Applicant
INTL. IMMUNOASSAY LABORATORIES, INC.
1900 wyatt dr., #11
santa clara,  CA  95054
Original Contact shah, ph.d.
Regulation Number862.1215
Classification Product Code
JHT  
Date Received03/28/1990
Decision Date 05/15/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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