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510(k) K781403

Device
FTA-ABS TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K781403
Product code
GMS  
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-21
Date received
1978-08-15
Regulation
866.3830
Classification name
Anti-human Globulin, Fta-abs Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
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 GMS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDImmuno-Products Industries1985-09-19
K843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBImmuno-Products Industries1984-10-31

Legacy Summary#

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FDA Review#

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