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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, Naphthyl Phosphate
510(k) Number K902495
Device Name ACID PHOSPHATASE REAGENT SET
Applicant
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Applicant Contact CHEN, PH.D.
Correspondent
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Correspondent Contact CHEN, PH.D.
Regulation Number862.1020
Classification Product Code
CKB  
Date Received06/05/1990
Decision Date 07/16/1990
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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