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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 K863719
Device Name AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
Applicant
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received09/23/1986
Decision Date 11/13/1986
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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