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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 K874284
Device Name SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
Applicant
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Applicant Contact NOEL RICHARD
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Correspondent Contact NOEL RICHARD
Regulation Number862.1215
Classification Product Code
JHT  
Date Received10/14/1987
Decision Date 01/21/1988
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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