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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alkaline picrate, colorimetry, creatinine
510(k) Number K860418
Device Name CREATININE 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 Number862.1225
Classification Product Code
CGX  
Date Received02/04/1986
Decision Date 02/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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