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510(k) K791049

Device
SYNALON ROLLER BOTTLE
Applicant
DYNATECH LABORATORIES, INC.
510(k) number
K791049
Product code
KJC  
Decision
Substantially Equivalent (SESE)
Decision date
1979-06-28
Date received
1979-06-06
Regulation
864.2240
Classification name
Bottle, Roller, Tissue 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 KJC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880509MULTISURFACE ROLLER BOTTLE (M.S.R.B.)Motil Plastics , Ltd.1988-04-01
K873137IN VITRO 2.5X ROLLER BOTTLEIn Vitro Scientific Products1987-08-24

Legacy Summary#

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FDA Review#

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