BACTEC MGIT 960 SYSTEM

System, Blood Culturing

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 Bactec Mgit 960 System.

Pre-market Notification Details

Device IDK974883
510k NumberK974883
Device Name:BACTEC MGIT 960 SYSTEM
ClassificationSystem, Blood Culturing
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville,  MD  21030 -0243
ContactJody J Hoffmann
CorrespondentJody J Hoffmann
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville,  MD  21030 -0243
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-30
Decision Date1998-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382904471613 K974883 000
00382904458706 K974883 000
00382904417437 K974883 000
00382902451242 K974883 000
30382902451229 K974883 000
00382904459994 K974883 000
00382904458713 K974883 000

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