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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
510(k) Number K860554
Device Name SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
Applicant
Sterling Diagnostics, Inc.
34210 Dequindre Rd.
Sterling Heights,  MI  48077
Applicant Contact DAVID L CALLENDER
Correspondent
Sterling Diagnostics, Inc.
34210 Dequindre Rd.
Sterling Heights,  MI  48077
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1465
Classification Product Code
CFG  
Date Received02/14/1986
Decision Date 03/14/1986
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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