FDA.reportPublic FDA data

510(k) K943194

Device
Immulite(r) Allergy Food Panel Fp5e
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K943194
Product code
DGO
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-23
Date received
1994-07-05
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
KENNETH B ASARCH
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

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
K920087IGE EIA TEST KITThe Binding Site, Ltd.1992-09-14
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K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.1989-07-14
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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