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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 K792289
Device Name LIPASE TEST KIT
Applicant
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1465
Classification Product Code
CET  
Date Received11/13/1979
Decision Date 12/18/1979
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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