DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST

Antisera, All Groups, Streptococcus Spp.

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 Directigen Meningitis Combo Test & (b) Strep Test.

Pre-market Notification Details

Device IDK870155
510k NumberK870155
Device Name:DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactRussell Arnsberger
CorrespondentRussell Arnsberger
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-13
Decision Date1987-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902554608 K870155 000

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