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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 K812836
Device Name LDH REAGENT SET
Applicant
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1440
Classification Product Code
CFH  
Date Received10/09/1981
Decision Date 10/09/1981
Decision SE - Postmarket Surveillance Required (SESP)
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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