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510(k) K960067

Device
IMMILITE TOTAL IGE
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K960067
Product code
JHR  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-14
Date received
1996-01-05
Regulation
866.5510
Classification name
Radioimmunoassay, Immunoglobulins (d, E)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD M LEVINE, PH.D.
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JHR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061970ELECSYS IGE II IMMUNOASSAYRoche Diagnostics2006-08-31
K984326ELECYS IGE ASSAYBoehringer Mannheim Corp.1999-02-08
K931703IMMULITE TOTAL IGEDiagnostic Products Corp.1993-08-16
K903000TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.1990-07-31
K901859COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.1990-05-03
K882616ALTERNATE PROCEDURE, PHARMACIA IGE EIAPharmacia, Inc.1988-08-04
K873077PHARMACIA IGE EIAPharmacia, Inc.1987-10-20
K840103RADIOIMMUNOASSAY FOR TOTAL IGE HUMANTechniclone Intl.1984-02-10

Legacy Summary#

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FDA Review#

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