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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Thymolphthale Inmonophosphate
510(k) Number K915705
Device Name ACID PHOSPHATASE REAGENT SET
Applicant
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact CHEN
Correspondent
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact CHEN
Regulation Number862.1020
Classification Product Code
CKE  
Date Received11/29/1991
Decision Date 02/27/1992
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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