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510(k) K853122

Device
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
Applicant
IMMUNO-PRODUCTS INDUSTRIES
510(k) number
K853122
Product code
GMS  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-19
Date received
1985-07-25
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#

Contact
HOWARD RUBINSTEIN
Address
P.O. Box 286 So. Bound Brook NJ US 08880 08880

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
K843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBImmuno-Products Industries1984-10-31
K781403FTA-ABS TEST SYSTEMZeus Scientific, Inc.1978-08-21

Legacy Summary#

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FDA Review#

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