AMES TDA PROCAINAMIDE TEST

Enzyme Immunoassay, Procainamide

MILES LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK831400
510k NumberK831400
Device Name:AMES TDA PROCAINAMIDE TEST
ClassificationEnzyme Immunoassay, Procainamide
Applicant MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLAR  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-29
Decision Date1983-06-02

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