MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578

Tubes, Vials, Systems, Serum Separators, Blood Collection

BECTON DICKINSON VACUTAINER SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Microtainer Brand Chemistry Tubes With Microgard Closure, Model 365965, 365985, 365963, 365967, 36578.

Pre-market Notification Details

Device IDK991702
510k NumberK991702
Device Name:MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes,  NJ  07417 -1885
ContactAndrea Hroncicch
CorrespondentAndrea Hroncicch
BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes,  NJ  07417 -1885
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-19
Decision Date1999-07-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903659871 K991702 000
30382903659655 K991702 000
30382903659877 K991702 000
30382903659631 K991702 000
30382903659785 K991702 000
30382903659853 K991702 000
50382903659635 K991702 000
50382903659659 K991702 000
50382903659673 K991702 000
50382903659741 K991702 000
50382903659789 K991702 000
50382903659857 K991702 000
30382903659679 K991702 000

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