FDA.reportPublic FDA data

510(k) K843613

Device
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
Applicant
IMMUNO-PRODUCTS INDUSTRIES
510(k) number
K843613
Product code
GMS  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-31
Date received
1984-09-10
Regulation
866.3830
Classification name
Anti-human Globulin, Fta-abs Test
Medical specialty
Microbiology
Review panel
Immunology
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
K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDImmuno-Products Industries1985-09-19
K781403FTA-ABS TEST SYSTEMZeus Scientific, Inc.1978-08-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases