Terumo Imugard

FDA 510(k) K790105 · Terumo America, Inc.

Substantially Equivalent

510(k) numberK790105

Submission

Device name
Terumo Imugard
Applicant
Terumo America, Inc.
Mchenry, IL, US
Received
January 16, 1979
Decision date
May 24, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKT – Separator, Automated, Blood Cell, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 864.9245
Specialty
Hematology

Other 510(k)s with product code GKT

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K200530AMICUS Separator SystemGKT · Traditional Fresenius Kabi AG09/11/2020SE
K162462AMICUS Separator System, AMICUS Separator System; RefurbishedGKT · Traditional Fresenius Kabi USA,Llc11/23/2016SE
K822521Automated Blood Cell SeparatorGKT · Traditional Cryosan, Inc.09/30/1982SE
K820396Automated Blood Cell Separ. Disp. SftwrGKT · Traditional Pheragen Technology Corp.04/27/1982SE
K801233Celltrifuge IIGKT · Traditional Travenol Laboratories, S.A.10/31/1980SE
K791106Sterile, Disposable Centrifuge BowlGKT · Traditional Travenol Laboratories, S.A.08/10/1979SE
K781803Filter, Eyrpur Disposable LeukociteGKT · Traditional Metrix Teknika, Inc.01/17/1979SE
K771258Blood Cell Separator 2997GKT · Traditional Intl. Business Machines09/06/1977SE
K760856Blood Cell Processor Model 2 IBM 2991GKT · Traditional Intl. Business Machines01/10/1977SE

More from Intl. Business Machines

510(k)DeviceDecision
K811523Plasma FlexKSR · Traditional 09/09/1981SE
K802970Terumo Hollow Fiber OxygenatorDTZ · Traditional 01/22/1981SE
K802441Clirans TH10 Hollow Fiber DialyzerFJI · Traditional 12/18/1980SE
K802122Clirans TH13 Hollow Fiber DialyzerFJI · Traditional 12/18/1980SE
K801194Clirans TE07 Hollow Fiber DialyzerFJI · Traditional 08/12/1980SE
K801193Clirans TE15 Hollow Fiber DialyzerKDJ · Traditional 08/12/1980SE
K801192Clirans TE10 Hollow Fiber DialyzerFJI · Traditional 08/12/1980SE
K791411Coaxial Dual Flow CatheterKOC · Traditional 11/13/1979SE
K791173Surflo Injection PlugFPA · Traditional 07/30/1979SE
K772362Avf Set for Single Needle HemodialysisFIE · Traditional 03/17/1978SE

Questions and answers

When was Terumo Imugard cleared by the FDA?

Terumo Imugard (K790105) received a 510(k) decision of Substantially Equivalent on May 24, 1979, 128 days after the submission was received.

What is the product code of K790105?

The FDA product code is GKT – Separator, Automated, Blood Cell, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 864.9245.