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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
Predetermined Change
Control Plan Authorized		 No
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