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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amyloclastic, Amylase
510(k) Number K862640
Device Name AMYLASE LTS
Applicant
ELECTRO-NUCLEONICS LABORATORIES, INC.
7101 RIVERWOOD DR.
COLUMBIA,  MD  21046
Applicant Contact LABREC, PH.D.
Correspondent
ELECTRO-NUCLEONICS LABORATORIES, INC.
7101 RIVERWOOD DR.
COLUMBIA,  MD  21046
Correspondent Contact LABREC, PH.D.
Regulation Number862.1070
Classification Product Code
CJA  
Date Received07/10/1986
Decision Date 09/09/1986
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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