Atlas FDA

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes

FDA 510(k) clearance K213670 · decided 2023-08-25

Clearance details

K-number
K213670
Device name
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2021-11-22
Decision date
2023-08-25
Days to decision
641 days
Clearance type
Traditional
Product code
GIM
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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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BD Vacutainer® Citrate Blood Collection Tubes (K240455)Becton, Dickinson and Company2024-10-31
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (K230493)Becton, Dickinson and Company2023-11-27
TransFix/EDTA Vacuum Blood Collection Tubes (K162723)Caltag Medsystems, Ltd.2017-06-22
CYTO-CHEX BCT (K080552)Streck2008-07-31
DS30 HCY BLOOD COLLECTION TUBES (K012152)Drew Scientific , Ltd.2001-09-18
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (K971449)Becton Dickinson Vacutainer Systems1997-06-17
GREINER VACUETTE BLOOD COLLECTION TUBE (K971221)Greiner America, Inc.1997-05-02
LOK-ON NEEDLE DISPOSAL SYSTEM (K951886)Becton Dickinson Vacutainer Systems1995-06-30
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (K945458)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
CORVAC PLASTIC BLOOD COLLECTION TUBE (K944814)Sherwood Medical Co.1994-12-19
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER (K940058)Sherwood Medical Co.1994-05-02
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT (K933939)Organon Teknika Corp.1994-02-07

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15