BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774

Tubes, Vials, Systems, Serum Separators, Blood Collection

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Rapid Serum Tube Blood Collection Tube, Model 368774.

Pre-market Notification Details

Device IDK101502
510k NumberK101502
Device Name:BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BECTON DICKINSON & CO. 1 BECTON DRIVE, MC300 Franklin Lakes,  NJ  07417 -1885
ContactMary Anne Alsberge
CorrespondentMary Anne Alsberge
BECTON DICKINSON & CO. 1 BECTON DRIVE, MC300 Franklin Lakes,  NJ  07417 -1885
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-01
Decision Date2010-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903687744 K101502 000
30859952006407 K101502 000
30859952006094 K101502 000
30859952006070 K101502 000
30859952006063 K101502 000
50859952006050 K101502 000
30859952006032 K101502 000
30859952006025 K101502 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.