TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD

Radioimmunoassay, Tobramycin

TECHNICON INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra Systems Tobramycin Test Method.

Pre-market Notification Details

Device IDK893913
510k NumberK893913
Device Name:TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
ClassificationRadioimmunoassay, Tobramycin
Applicant TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactLeonard A Dwarica
CorrespondentLeonard A Dwarica
TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeKLB  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-30
Decision Date1989-08-21

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