AMES TDA QUINIDINE TEST

Enzyme Immunoassay, Quinidine

MILES LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK812753
510k NumberK812753
Device Name:AMES TDA QUINIDINE TEST
ClassificationEnzyme Immunoassay, Quinidine
Applicant MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBZ  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-29
Decision Date1981-10-19

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