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510(k) K864966

Device
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
Applicant
DIAGNOSTICS BIOCHEM CANADA, INC.
510(k) number
K864966
Product code
CGF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-09
Date received
1986-12-22
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
1020 Hargrieve Rd. London, Ontario CA N6E 1P5 N6E 1P5

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
K833406IMMOPHASE D-TE 3 RADIOIMMUNOASSAYCorning Medical & Scientific1984-01-24

Legacy Summary#

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FDA Review#

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