FDA.reportPublic FDA data

510(k) K760856

Device
BLOOD CELL PROCESSOR MODEL 2 IBM 2991
Applicant
INTL. BUSINESS MACHINES
510(k) number
K760856
Product code
GKT  
Decision
Substantially Equivalent (SESE)
Decision date
1977-01-10
Date received
1976-10-15
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

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKT  #

510(k), Device, Applicant table
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
K791106STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.1979-08-10
K790105TERUMO IMUGARDTerumo America, Inc.1979-05-24
K781803FILTER, EYRPUR DISPOSABLE LEUKOCITEMetrix Teknika, Inc.1979-01-17
K771258BLOOD CELL SEPARATOR 2997Intl. Business Machines1977-09-06

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases