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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saccharogenic, Amylase
510(k) Number K023396
Device Name AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
Applicant
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Applicant Contact RON JAMISON
Correspondent
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Correspondent Contact RON JAMISON
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received10/09/2002
Decision Date 12/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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