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510(k) K833406

Device
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
Applicant
CORNING MEDICAL & SCIENTIFIC
510(k) number
K833406
Product code
CGF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-24
Date received
1983-09-30
Regulation
862.1280
Classification name
Radioimmunoassay, Estrone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
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 CGF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970915DSL ESTRONE-SULFATE RIADiagnostic Systems Laboratories, Inc.1997-05-16
K935013DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc.1994-06-16
K864966ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONEDiagnostics Biochem Canada, Inc.1987-01-09

Legacy Summary#

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FDA Review#

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