OPTIMATE IGM TEST

Igm, Antigen, Antiserum, Control

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Optimate Igm Test.

Pre-market Notification Details

Device IDK841814
510k NumberK841814
Device Name:OPTIMATE IGM TEST
ClassificationIgm, Antigen, Antiserum, Control
Applicant MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDFT  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-01
Decision Date1984-06-22

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