FDA.reportPublic FDA data

510(k) K840103

Device
Radioimmunoassay For Total Ige Human
Applicant
TECHNICLONE INTL.
510(k) number
K840103
Product code
JHR
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-10
Date received
1984-01-10
Regulation
866.5510
Classification name
Radioimmunoassay, Immunoglobulins (D, E)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K960067IMMILITE TOTAL IGEDiagnostic Products Corp.1996-02-14
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