RAT BLOOD IN ALSEVER'S, CITRATED

Staphylococcus Aureus Somatic Antigens

DUTCHLAND LABORATORIES, INC.

The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Rat Blood In Alsever's, Citrated.

Pre-market Notification Details

Device IDK812368
510k NumberK812368
Device Name:RAT BLOOD IN ALSEVER'S, CITRATED
ClassificationStaphylococcus Aureus Somatic Antigens
Applicant DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHT  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-20
Decision Date1981-09-09

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