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510(k) K913670

Device
HAPTOGLOBIN IMMUNOLOGICAL TEST KIT
Applicant
THE BINDING SITE, LTD.
510(k) number
K913670
Product code
DAB  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-09
Date received
1991-08-19
Regulation
866.5460
Classification name
Haptoglobin, Fitc, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAY H GELLER
Address
Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843570FIAX HAPTOGLOBIN TEST KITIntl. Diagnostic Technology1984-10-05
K772078RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINGelman Instrument Co.1978-02-03

Legacy Summary#

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FDA Review#

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