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510(k) K913671

Device
HUMAN IGD IMMUNOLOGICAL NL TEST KIT
Applicant
THE BINDING SITE, LTD.
510(k) number
K913671
Product code
CZJ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-02
Date received
1991-08-19
Regulation
866.5510
Classification name
Igd, 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 CZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092450HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding Site2009-12-28
K051299IGD DIAGNOSTIC TEST KITSThe Binding Site, Ltd.2005-11-23
K002561SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.2000-10-26
K883001QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22
K872834TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410Helena Laboratories1987-08-12
K831956DETERM. SIZE 72 RADIAL-HUMAN IGDKent Laboratories, Inc.1983-07-18
K772327LAS-R HUMAN IGD TESTHyland Therapeutic Div., Travenol Laboratories1978-02-28

Legacy Summary#

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FDA Review#

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