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510(k) K853067

Device
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
Applicant
IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
510(k) number
K853067
Product code
GRE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-22
Date received
1985-07-22
Regulation
866.3520
Classification name
Antiserum, Fluorescent, Rubeola
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LOUISE HARRIS
Address
2050 Concourse Dr. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GRE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884004RUBEOLA TESTGull Laboratories, Inc.1988-12-05
K821249ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUSElectro-Nucleonics Laboratories, Inc.1982-07-30
K770687MEASLESVIRUS FLOURE. CONJUGATED ANTISERUMicrobiological Assoc.1977-06-14

Legacy Summary#

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FDA Review#

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