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510(k) K780305

Device
CELL
Applicant
DYNATECH LABORATORIES, INC.
510(k) number
K780305
Product code
KJF  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-27
Date received
1978-02-23
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#

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 KJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893787LIFECELL RECOVERY CONTAINERBaxter Healthcare Corp1989-06-23
K892645AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SYAmicon, Inc.1989-06-13
K875221TOOTH PRESERVING SYSTEMBiological Rescue Products, Inc.1988-04-14

Legacy Summary#

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FDA Review#

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