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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 K931172
Device Name IMX(R) STAT CK-MB
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact JOY C SONSALLA
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact JOY C SONSALLA
Regulation Number862.1215
Classification Product Code
JHY  
Date Received03/08/1993
Decision Date 06/15/1993
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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