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510(k) K893125

Device
Beckman Epsilon(tm) Ige Reagent Kit
Applicant
BECKMAN INSTRUMENTS, INC.
510(k) number
K893125
Product code
DGO
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-16
Date received
1989-04-25
Regulation
866.5510
Classification name
Ige, Peroxidase, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM T RYAN
Address
200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622

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
K920087IGE EIA TEST KITThe Binding Site, Ltd.1992-09-14
K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.1991-04-17
K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.1989-07-14
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