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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tetrazolium int dye-diaphorase, lactate dehydrogenase
510(k) Number K820768
Device Name COLORIMETRIC LDH REAGENT SET
Applicant
BIORENT DIAGNOSTIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIORENT DIAGNOSTIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1440
Classification Product Code
CFH  
Date Received03/22/1982
Decision Date 04/14/1982
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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