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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K880237
Device Name CHOLESTEROL
Applicant
TECH-NEAL SCIENTIFIC, INC.
817 OAKWOOD DR.
WESTMONT,  IL  60559
Applicant Contact ARUN SANGHAVI
Correspondent
TECH-NEAL SCIENTIFIC, INC.
817 OAKWOOD DR.
WESTMONT,  IL  60559
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1175
Classification Product Code
CHH  
Date Received01/20/1988
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
Recalls CDRH Recalls
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