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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K853373
Device Name DELTA TROL I & II
Applicant
ELECTRO-NUCLEONICS LABORATORIES, INC.
7101 RIVERWOOD DR.
COLUMBIA,  MD  21046
Applicant Contact EUGENE H LABREC
Correspondent
ELECTRO-NUCLEONICS LABORATORIES, INC.
7101 RIVERWOOD DR.
COLUMBIA,  MD  21046
Correspondent Contact EUGENE H LABREC
Regulation Number862.1660
Classification Product Code
JJT  
Date Received08/12/1985
Decision Date 08/23/1985
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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