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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 K844240
Device Name ENZYGNOST LIPASE TEST
Applicant
BEHRING DIAGNOSTICS, INC.
10933 NO TORREY PINES RD.
LA JOLLA,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
BEHRING DIAGNOSTICS, INC.
10933 NO TORREY PINES RD.
LA JOLLA,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number862.1465
Classification Product Code
CET  
Date Received11/01/1984
Decision Date 02/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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