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)
Top companies in JKA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2026 | Greiner 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 |
JKA | K960857 |
| Jan 15, 2026 | ICU Medical Inc. Pulsator Arterial Blood Sampling Kit, Item Numbers
4044EG-1
4080P-2
4084P-1
4080PE
4080PG Open, Classified |
JKA | K952516 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | ASP 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 |
JKA | K983517 |
| Nov 19, 2025 | Greiner 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 |
JKA | K081929 K983952 |
| Oct 27, 2025 | ASP 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 |
JKA | K981973 |
| Jul 17, 2024 | Greiner Bio-One North America, Inc. VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100
red cap-yellow ring, non-ridged Open, Classified |
JKA | K081929 K960858 +1 |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545 Open, Classified |
JKA | None listed |
| Jan 16, 2024 | Greiner 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 |
JKA | K971239 |
| Oct 20, 2023 | Smiths Medical ASD Inc. Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 Open, Classified |
JKA | K952516 |
| May 12, 2023 | Greiner 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 |
JKA | K960860 |
| Oct 14, 2022 | Becton 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 |
JKA | None listed |
| Aug 26, 2022 | Mckesson 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 |
JKA | BK050036 |
| Apr 8, 2022 | Radiometer 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 |
JKA | K962158 |
| Jan 6, 2022 | Becton 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 |
JKA | K991088 |
| Dec 9, 2021 | Greiner 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 |
JKA | K960857 |
| Nov 10, 2021 | Velano Vascular PIVO Blood Collection Device 20G, REF: 202-0005 Terminated |
JKA | K193569 |
| Nov 2, 2021 | Magnolia 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 |
JKA | K192247 |
| Aug 13, 2021 | Greiner Bio-One North America, Inc. VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Terminated |
JKA | K971236 |
| Aug 2, 2021 | Magnolia 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 |
JKA | K192247 |
| Jul 6, 2021 | Advance 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 |
JKA | None listed |
| Mar 26, 2021 | Radiometer 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 |
JKA | None listed |
| Aug 28, 2020 | Greiner 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 |
JKA | K081929 |
| Apr 15, 2020 | Smiths Medical ASD, Inc. Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Terminated |
JKA | K952516 |
| Apr 15, 2020 | Smiths Medical ASD, Inc. Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes Terminated |
JKA | K952516 |
| Apr 3, 2020 | C.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 |
JKA | None listed |
| Nov 25, 2019 | Greiner 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 |
JKA | K983952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886 Terminated |
JKA | K901449 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884 Terminated |
JKA | K901449 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056 Terminated |
JKA | K944566 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036 Terminated |
JKA | K944566 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886 Terminated |
JKA | K945952 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884 Terminated |
JKA | K901449 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880 Terminated |
JKA | K901449 |
| Jun 12, 2019 | Becton Dickinson & Company BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667 Terminated |
JKA | K901449 |
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