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510(k) K892645

Device
AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY
Applicant
AMICON, INC.
510(k) number
K892645
Product code
KJF  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-13
Date received
1989-04-12
Regulation
864.2240
Classification name
System, Suspension, Cell Culture
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES M DELANEY
Address
17 Cherry Hill Dr. Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893787LIFECELL RECOVERY CONTAINERBaxter Healthcare Corp1989-06-23
K875221TOOTH PRESERVING SYSTEMBiological Rescue Products, Inc.1988-04-14
K780305CELLDynatech Laboratories, Inc.1978-03-27

Legacy Summary#

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FDA Review#

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