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510(k) K920087

Device
Ige Eia Test Kit
Applicant
THE BINDING SITE, LTD.
510(k) number
K920087
Product code
DGO
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-14
Date received
1992-01-08
Regulation
866.5510
Classification name
Ige, Peroxidase, 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 DGO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.1995-02-23
K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.1991-04-17
K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.1989-07-14
K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.1989-06-16
K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products Corp.1987-09-10
K860851ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEMNichols Institute Diagnostics1986-03-28
K853607ALLERG-E IGE ENZYME IMMUNOASSAY KITDexall Biomedical Labs, Inc.1985-11-07
K831984POLYSTYRENE MICRO-LITER PLATE-BIRCHTREEDiagnostic Reagent Tech.1983-11-21
K831987EPSILON IGE TEST KITBeckman Instruments, Inc.1983-10-14
K831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-Diagnostic Reagent Tech.1983-07-18
K830653POLYSTYRENE MICROTITER PLATE IMMUNOSORBDiagnostic Reagent Tech.1983-04-08
K830495POLYSTYRENE MICROTITER PLATE IMMUNOSORDiagnostic Reagent Tech.1983-04-05
K821094IP SPECIFIC EDiagnostic Reagent Tech.1982-05-07
K800995IMMUNOGLOBULIN E TEST KITCalbiochem-Behring Corp.1980-05-14