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

Company	510(k)s	Recalls
Becton, Dickinson & CO	8	68
Smiths Medical Asd, Inc.	2	32
Becton, Dickinson and Company	19	0
Greiner Bio-One North America, Inc.	5	14
Bd Becton Dickinson Vacutainer Systems Preanalytic	13	0
ASP Global, LLC. dba Anatomy Supply Partners, LLC.	0	12
Becton Dickinson Vacutainer Systems	11	0
Sherwood Medical Co.	9	0
Immunetech Corporation	2	6
Velano Vascular	6	1

Date	Firm and product	Code	Linked 510(k)
Aug 30, 2005	Becton Dickinson & Company BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve. Terminated	JKA	K990188
Mar 1, 2005	Greer Laboratories Inc Sterile Empty Vials for Allergenic Extracts, 100ml size Terminated	JKA	None listed
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1696 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1615 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1576 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1562 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1560 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1554 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1540 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1515 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1488 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1483 Terminated	JKA	None listed
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1481 Terminated	JKA	K952516
Nov 24, 2004	Smiths Medical ASD, Inc. Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Catalog Number: 4589P-1 Terminated	JKA	K952516
Oct 28, 2004	Becton Dickinson & Company BD Vacutainer Microtainer Serum tubes (with or without gel). Terminated	JKA	K002456 K771370 +3
Oct 28, 2004	Becton Dickinson & Company BD Vacutainer Partial Draw serum tubes (with or without gel). Terminated	JKA	BK040030
Oct 28, 2004	Becton Dickinson & Company BD Vactuainer SST glass and plastic tubes. Terminated	JKA	K023075 K921806 +1
Feb 25, 2004	Becton Dickinson & Company VACUTAINER Brand Push Button Blood Collection Sets. Terminated	JKA	K011984
Feb 4, 2004	Stockwell Scientific Inc 50 mL sterile plastic centerfuge tubes. Terminated	JKA	None listed
May 9, 2003	Greiner VACUETTE North America Vacuette, Safety Blood Collection Set with Luer Adapter Terminated	JKA	K011786
Jan 16, 2003	Becton Dickinson & Company Microtainer Brand Tube with EDTA (K2), Catalog Number 365974. Terminated	JKA	K940905

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