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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 K914160
Device Name CHOLESTEROL REGEANT SET
Applicant
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Correspondent
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Regulation Number862.1175
Classification Product Code
CHH  
Date Received09/17/1991
Decision Date 01/30/1992
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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