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510(k) K903000

Device
TURBO-RAST SPECIFIC IGE ASSAY
Applicant
VENTREX LABORATORIES, INC.
510(k) number
K903000
Product code
JHR  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-31
Date received
1990-07-09
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#

Contact
JAMES W CHAMPLIN
Address
217 Read St. P.O. Box 9731 Portland ME US 04103 04103

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
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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