Hema(Pro)Tec(Tion)

FDA 510(k) K885324 · Medical Products Search, Inc.

Substantially Equivalent

510(k) numberK885324

Submission

Device name
Hema(Pro)Tec(Tion)
Applicant
Medical Products Search, Inc.
Winston-Salem, NC, US
Received
December 28, 1988
Decision date
February 17, 1989
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)DeviceApplicantDecision
K972969Quick-Draw Capillary Whole Blood Collection SystemGIO · Traditional Innovative Medical Technologies, Inc.09/22/1997SE
K941291Monoject Samplette Separator TubeGIO · Traditional Sherwood Medical Co.10/27/1994SE
K894851Tru-TraxGIO · Traditional Humagen, Inc.09/29/1989SE
K885138Capillary Tube, Blood CollectionGIO · Traditional Coeur Laboratories, Inc.02/07/1989SE
K884623Safe-Tec Capillary Blood Collection TubeGIO · Traditional Safe-Tec Clinical Products, Inc.12/01/1988SE
K881262Caraway Tubes, Heparin and PlainGIO · Traditional Helps Products, Inc.05/06/1988SE
K881187Natelson Tubes, Heparin and PlainGIO · Traditional Helps Products, Inc.05/06/1988SE
K875061Monoject Samplette Amber Capillary Serum SeparatorGIO · Traditional Sherwood Medical Co.01/12/1988SE
K873647Ventrescreen Capillary Blood Collection TubeGIO · Traditional Ventrex Laboratories, Inc.10/20/1987SE
K850806Corning Blood Collection Capillary TubesGIO · Traditional Corning Medical & Scientific03/25/1985SE

More from Corning Medical & Scientific

510(k)DeviceDecision
K905665Patient Examination GlovesLYY · Traditional 01/15/1991SE
K874454Iv-Push, Constant Infusion PumpKZD · Traditional 11/06/1987SE

Questions and answers

When was Hema(Pro)Tec(Tion) cleared by the FDA?

Hema(Pro)Tec(Tion) (K885324) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 51 days after the submission was received.

What is the product code of K885324?

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