Caraway Tubes, Heparin and Plain

Q: What is the product code of K881262?

The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.

FDA 510(k) K881262 · Helps Products, Inc.

Substantially Equivalent

510(k) numberK881262

Submission

Device name: Caraway Tubes, Heparin and Plain
Applicant: Helps Products, Inc.
Orlando, FL, US
Received: March 24, 1988
Decision date: May 6, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GIO – Tube, Collection, Capillary Blood
Device class: Class I (low risk)
Regulation: 21 CFR 864.6150
Specialty: Hematology

Other 510(k)s with product code GIO

510(k)	Device	Applicant	Decision
K972969	Quick-Draw Capillary Whole Blood Collection SystemGIO · Traditional	Innovative Medical Technologies, Inc.	09/22/1997SE
K941291	Monoject Samplette Separator TubeGIO · Traditional	Sherwood Medical Co.	10/27/1994SE
K894851	Tru-TraxGIO · Traditional	Humagen, Inc.	09/29/1989SE
K885324	Hema(Pro)Tec(Tion)GIO · Traditional	Medical Products Search, Inc.	02/17/1989SE
K885138	Capillary Tube, Blood CollectionGIO · Traditional	Coeur Laboratories, Inc.	02/07/1989SE
K884623	Safe-Tec Capillary Blood Collection TubeGIO · Traditional	Safe-Tec Clinical Products, Inc.	12/01/1988SE
K881187	Natelson Tubes, Heparin and PlainGIO · Traditional	Helps Products, Inc.	05/06/1988SE
K875061	Monoject Samplette Amber Capillary Serum SeparatorGIO · Traditional	Sherwood Medical Co.	01/12/1988SE
K873647	Ventrescreen Capillary Blood Collection TubeGIO · Traditional	Ventrex Laboratories, Inc.	10/20/1987SE
K850806	Corning Blood Collection Capillary TubesGIO · Traditional	Corning Medical & Scientific	03/25/1985SE

More from Corning Medical & Scientific

510(k)	Device	Decision
K881188	Blood PH Capillary Tubes, HeparinCHL · Traditional	07/08/1988SE
K881186	Microhematocrit Tubes, Heparin & Microhema Tube,PlGHY · Traditional	05/13/1988SE
K881187	Natelson Tubes, Heparin and PlainGIO · Traditional	05/06/1988SE

Questions and answers

When was Caraway Tubes, Heparin and Plain cleared by the FDA?

Caraway Tubes, Heparin and Plain (K881262) received a 510(k) decision of Substantially Equivalent on May 6, 1988, 43 days after the submission was received.

What is the product code of K881262?

The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.