SIMULTEST(TM) IMK-LYMPHOCYTE

Counter, Differential Cell

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Simultest(tm) Imk-lymphocyte.

Pre-market Notification Details

Device IDK913192
510k NumberK913192
Device Name:SIMULTEST(TM) IMK-LYMPHOCYTE
ClassificationCounter, Differential Cell
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactJ Arnsberger
CorrespondentJ Arnsberger
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-18
Decision Date1992-02-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903401826 K913192 000
00382903400447 K913192 000
00382903400430 K913192 000

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