AMES TDA TM AMIKACIN TEST

Radioimmunoassay, Amikacin

MILES LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK811026
510k NumberK811026
Device Name:AMES TDA TM AMIKACIN TEST
ClassificationRadioimmunoassay, Amikacin
Applicant MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-16
Decision Date1981-04-29

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