AFRICAN GREEN MONKEY BLOOD IN ALSERVERS

Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment

DUTCHLAND LABORATORIES, INC.

The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for African Green Monkey Blood In Alservers.

Pre-market Notification Details

Device IDK813513
510k NumberK813513
Device Name:AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
ClassificationErythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Applicant DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHW  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-15
Decision Date1981-12-31

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