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Panels › Clinical Chemistry › Product code JKA · Class 2

Tubes, Vials, Systems, Serum Separators, Blood Collection

Regulation 862.1675

8510(k)s in 12 months (239 all time)
14recalls in 12 months (171 all time)
156recalls that name a 510(k)
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Top companies in JKA

DateFirm and productCodeLinked 510(k)
Oct 21, 2026Greiner Bio-One North America, Inc.
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 7
Open, Classified
JKAK960857
Jan 15, 2026ICU Medical Inc.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Open, Classified
JKAK952516
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a col
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a co
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a co
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood C
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a colle
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a colle
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Coll
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Coll
Open, Classified
JKAK983517
Nov 19, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a co
Open, Classified
JKAK983517
Nov 19, 2025Greiner Bio-One North America, Inc.
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separat
Open, Classified
JKAK081929
K983952
Oct 27, 2025ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA Self-seali
Open, Classified
JKAK981973
Jul 17, 2024Greiner Bio-One North America, Inc.
VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Open, Classified
JKAK081929
K960858 +1
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
Open, Classified
JKANone listed
Jan 16, 2024Greiner Bio-One North America, Inc.
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Open, Classified
JKAK971239
Oct 20, 2023Smiths Medical ASD Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Open, Classified
JKAK952516
May 12, 2023Greiner Bio-One North America, Inc.
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Completed
JKAK960860
Oct 14, 2022Becton Dickinson & Company
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Open, Classified
JKANone listed
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLA
Open, Classified
JKABK050036
Apr 8, 2022Radiometer Medical ApS
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Open, Classified
JKAK962158
Jan 6, 2022Becton Dickinson & Company
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample co
Open, Classified
JKAK991088
Dec 9, 2021Greiner Bio-One North America, Inc.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Terminated
JKAK960857
Nov 10, 2021Velano Vascular
PIVO Blood Collection Device 20G, REF: 202-0005
Terminated
JKAK193569
Nov 2, 2021Magnolia Medical Technologies, Inc.
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wid
Terminated
JKAK192247
Aug 13, 2021Greiner Bio-One North America, Inc.
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Terminated
JKAK971236
Aug 2, 2021Magnolia Medical Technologies, Inc.
Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Colle
Terminated
JKAK192247
Jul 6, 2021Advance Dx, Inc.
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separatin
Terminated
JKANone listed
Mar 26, 2021Radiometer Medical ApS
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrol
Terminated
JKANone listed
Aug 28, 2020Greiner Bio-One North America, Inc.
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical
Terminated
JKAK081929
Apr 15, 2020Smiths Medical ASD, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Terminated
JKAK952516
Apr 15, 2020Smiths Medical ASD, Inc.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Terminated
JKAK952516
Apr 3, 2020C.A. Greiner & Sohne Gesellschaftmbh
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.
Terminated
JKANone listed
Nov 25, 2019Greiner Bio-One North America, Inc.
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are
Terminated
JKAK983952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
Terminated
JKAK901449
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Terminated
JKAK901449
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Terminated
JKAK944566
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
Terminated
JKAK944566
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
Terminated
JKAK945952
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
Terminated
JKAK901449
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
Terminated
JKAK901449
Jun 12, 2019Becton Dickinson & Company
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
Terminated
JKAK901449

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