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510(k) K820396

Device
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
Applicant
PHERAGEN TECHNOLOGY CORP.
510(k) number
K820396
Product code
GKT  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-27
Date received
1982-02-11
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
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)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
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
K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991Intl. Business Machines1977-01-10

Legacy Summary

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FDA Review

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