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510(k) K940037

Device
I.D. AND SEAKEM GTG AGAROSES
Applicant
FMC CORP.
510(k) number
K940037
Product code
JZR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-24
Date received
1994-01-04
Regulation
866.4900
Classification name
Support Gels
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MELVIN S DROZEN
Address
1001 G St., NW Sutie 500 W. Washington DC US 20001 20001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831603TITAN GE/IEPLATEHelena Laboratories1983-07-07

Legacy Summary#

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FDA Review#

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