FDA.report

510(k) K771258

Device
BLOOD CELL SEPARATOR 2997
Applicant
Intl. Business Machines
510(k) number
K771258
Product code
GKT
Decision
Substantially Equivalent (SESE)
Decision date
1977-09-06
Date received
1977-07-12
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
N

Related Records

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

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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
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K790105TERUMO IMUGARDTerumo America, Inc.1979-05-24
K781803FILTER, EYRPUR DISPOSABLE LEUKOCITEMetrix Teknika, Inc.1979-01-17
K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991Intl. Business Machines1977-01-10