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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K843007
Device Name CARDI-CK EIA TEST KIT CK-MB ISOENZYME
Applicant
Intl. Immunoassay Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Immunoassay Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1215
Classification Product Code
JHS  
Date Received07/31/1984
Decision Date 09/07/1984
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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