FDA.report

510(k) K791106

Device
Sterile, Disposable Centrifuge Bowl
Applicant
TRAVENOL LABORATORIES, S.A.
510(k) number
K791106
Product code
GKT
Decision
Substantially Equivalent (SESE)
Decision date
1979-08-10
Date received
1979-06-13
Regulation
864.9245
Classification name
Separator, Automated, Blood Cell, Diagnostic
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKT

510(k)DeviceApplicantDecision date
K200530AMICUS Separator SystemFresenius Kabi AG2020-09-11
K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc2016-11-23
K822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.1982-09-30
K820396AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.1982-04-27
K801233CELLTRIFUGE IITravenol Laboratories, S.A.1980-10-31
K790105TERUMO IMUGARDTerumo America, Inc.1979-05-24
K781803FILTER, EYRPUR DISPOSABLE LEUKOCITEMetrix Teknika, Inc.1979-01-17
K771258BLOOD CELL SEPARATOR 2997Intl. Business Machines1977-09-06
K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991Intl. Business Machines1977-01-10