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510(k) K860900

Device
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
Applicant
SCLAVO, INC.
510(k) number
K860900
Product code
CGI  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-28
Date received
1986-03-10
Regulation
862.1265
Classification name
Radioimmunoassay, Estriol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL BRINKLEY
Address
1240 Elko Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.1998-03-03
K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.1996-08-23
K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.1996-05-15
K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.1994-12-19
K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OY1994-12-09
K920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company1992-03-23
K903359MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KITImmunotech Corp.1990-08-22
K850787SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAYNms Pharmaceuticals, Inc.1985-03-26
K844767RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TOBiotecx Laboratories, Inc.1985-02-01
K844511TDX TOTAL ESTRIOLAbbott Laboratories1985-01-18
K844408AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATEDAmersham Corp.1984-12-11
K840902ENDAB ESTRIOL UNCONJUGATEDImmunotech Corp.1984-04-18
K840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITNew England Nuclear1984-03-30
K830816DSL 1900Diagnostic Systems1983-04-12
K823202FREE & TOTAL ESTRIOL KITDiagnostic Products Corp.1982-12-15

Legacy Summary#

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FDA Review#

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