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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K880177
Device Name ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
Applicant
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Applicant Contact HAPPY CHEN
Correspondent
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Correspondent Contact HAPPY CHEN
Regulation Number862.1050
Classification Product Code
CIO  
Date Received01/15/1988
Decision Date 04/05/1988
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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