IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS

Hemagglutination Inhibition, Gentamicin

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Gentamicin(gen)/tobramycin(tob) Reagent / Beckman Drug Claibrator 3 Plus.

Pre-market Notification Details

Device IDK964009
510k NumberK964009
Device Name:IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
ClassificationHemagglutination Inhibition, Gentamicin
Applicant BECKMAN INSTRUMENTS, INC. 2470 FARADAY Carlsbad,  CA  92008 -7224
ContactAnnette Hellie
CorrespondentAnnette Hellie
BECKMAN INSTRUMENTS, INC. 2470 FARADAY Carlsbad,  CA  92008 -7224
Product CodeDNO  
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-07
Decision Date1997-02-11
Summary:summary

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