Atlas FDA

BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube

FDA 510(k) clearance K160657 · decided 2016-09-23

Clearance details

K-number
K160657
Device name
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2016-03-08
Decision date
2016-09-23
Days to decision
199 days
Clearance type
Traditional
Product code
JKA
Device class
2
Regulation number
862.1675
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Vacutainer Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666 recall (Z-1142-2018)Becton Dickinson & Company2018-03-22

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