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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2020 | K202446 | BD Preset Syringe & BD A-Line Syringe Becton, Dickinson and Company | JKA |
| Sep 9, 2020 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-hold Jiangsu Caina Medical Co.,Ltd, CN | JKA |
| Apr 21, 2020 | K193074 | Bevel Up Holder Nsp Tech Pte, Ltd., SG | JKA |
| Feb 28, 2020 | K192247 | Steripath Gen2 Blood Collection System Magnolia Medical Technologies, Inc. | JKA |
| Feb 4, 2020 | K191832 | Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21 Kurin, Inc. | JKA |
| Jan 21, 2020 | K193569 | PIVO(TM) Velano Vascular | JKA |
| Jul 30, 2019 | K181754 | Blood Collection Accessory (BUCA) Nsp Tech Pte, Ltd., SG | JKA |
| Jul 30, 2019 | K181743 | Blood Transfer Accessory (BTA) Nsp Tech Pte, Ltd., SG | JKA |
| Jul 8, 2019 | K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Kawasumi Laboratories, Inc., JP | JKA |
| May 13, 2019 | K190604 | PIVO Velano Vascular | JKA |
| Jan 25, 2019 | K182078 | MiniCollect K2E K2EDTA Tubes Greiner Bio-One Na, Inc. | JKA |
| Jan 18, 2019 | K181895 | Kurin PIV Blood Collection Set with High Pressure Kurin, Inc. | JKA |
| Jun 4, 2018 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Ne Zhejiang Kindly Medical Devices Co., Ltd., CN | JKA |
| May 19, 2017 | K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder Sol-Millennium Medical, Inc. | JKA |
| Feb 9, 2017 | K163508 | PIVO Velano Vascular | JKA |
| Dec 23, 2016 | K162233 | Kurin Blood Culture Collection Set Pathway, LLC | JKA |
| Sep 23, 2016 | K160657 | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube Becton, Dickinson and Company | JKA |
| Feb 12, 2016 | K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set Becton, Dickinson and Company | JKA |
| Jan 7, 2016 | K152924 | TIVA¿ Velano Vascular | JKA |
| Jan 8, 2015 | K142946 | TIVA Velano Vascular, Inc. | JKA |
| Nov 19, 2014 | K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device Bio-Analysis, Inc. | JKA |
| Aug 27, 2013 | K123987 | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET Innovative Medical Technologies, Inc. | JKA |
| Aug 23, 2013 | K122355 | VANISHPOINT BLOOD COLLECTION SET Retractable Technologies, Inc. | JKA |
| Jan 10, 2013 | K122687 | BLOOD CULTURE HOLDER Greiner Bio-One North America, Inc. | JKA |
| Dec 27, 2012 | K120490 | QUICK SAMPLER HOLDER Nipro Medical Corporation | JKA |
| Nov 9, 2010 | K103041 | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR Greiner Bio-One North America, Inc. | JKA |
| Jul 12, 2010 | K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE Guangzhou Improve Medical Instruments Co., Ltd., CN | JKA |
| Jun 29, 2010 | K101502 | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 Becton, Dickinson & CO | JKA |
| Jan 21, 2010 | K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 Becton, Dickinson & CO | JKA |
| Aug 25, 2009 | K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 Becton, Dickinson and Company (BD) | JKA |
| Jun 3, 2009 | K090737 | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI Bio-Rad Laboratories, Inc. | JKA |
| Dec 16, 2008 | K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR Greiner Bio-One North America, Inc. | JKA |
| Jul 21, 2008 | K081229 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING Smiths Medical Asd, Inc. | JKA |
| Nov 30, 2007 | K072783 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH Smiths Medical Asd, Inc. | JKA |
| Nov 9, 2007 | K063852 | ACCESSA CHOLESTEROL PANEL Home Access Health Corp. | JKA |
| Oct 19, 2007 | K062932 | AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER Ahlstrom Mount Holly Springs, LLC | JKA |
| Jul 10, 2007 | K063357 | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES Greiner Bio-One North America, Inc. | JKA |
| Sep 22, 2006 | K061979 | MODIFICATION TO MYALLERGY TEST Immunetech Corporation | JKA |
| Jun 15, 2006 | K060364 | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE Teco Diagnostics | JKA |
| Jul 25, 2005 | K051019 | SAFETY NEEDLE Sarstedt, Inc. | JKA |
| Apr 22, 2005 | K043143 | SAFEPICO Radiometer Medical Aps, DK | JKA |
| Jul 27, 2004 | K040107 | CYTO-CHEX BCT Streck Laboratories, Inc. | JKA |
| May 28, 2004 | K041358 | VENOJECT LUER ADAPTER Terumo Europe N.V. | JKA |
| May 14, 2004 | K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 Becton, Dickinson & CO | JKA |
| Oct 27, 2003 | K030394 | FLUID SAMPLE RETRIEVAL SYSTEM Biomed Personal Metabolic and Nutritional Testing | JKA |
| Sep 17, 2003 | K030815 | AKERS LABORATORIES INC. BLOOD CELL SEPARATOR Akers Laboratories, Inc. | JKA |
| Aug 8, 2003 | K030596 | IMMUNICON CELLSAVE PRESERVATIVE TUBE Immunicon Corp. | JKA |
| Jul 7, 2003 | K030076 | PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM Biomed Personal Metabolic and Nutritional Testing | JKA |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 Bd Vacutainer Systems Preanalyical Solutions | JKA |
| Jan 27, 2003 | K023971 | VACUETTE TRACE ELEMENTS TUBES Greiner Bio-One Vacuette North America | JKA |
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