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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
510(k) Number K861855
Device Name HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
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 Number862.1380
Classification Product Code
JKF  
Date Received05/14/1986
Decision Date 06/16/1986
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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