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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 K881237
Device Name CREATINE KINASE (CK) REAGENT SET
Applicant
TECH-NEAL SCIENTIFIC, INC.
5410 S. KILPATRICK AVE.
CHICAGO,  IL  60632
Applicant Contact ARUN SANGHAVI
Correspondent
TECH-NEAL SCIENTIFIC, INC.
5410 S. KILPATRICK AVE.
CHICAGO,  IL  60632
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1215
Classification Product Code
JHX  
Date Received03/22/1988
Decision Date 04/28/1988
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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