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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Olive Oil Emulsion (Turbidimetric), Lipase
510(k) Number K893718
Device Name DELTATEST (R) LIPASE II
Applicant
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Applicant Contact KAREN H DARCY
Correspondent
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact KAREN H DARCY
Regulation Number862.1465
Classification Product Code
CET  
Date Received05/17/1989
Decision Date 09/28/1989
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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