510(k) K943193

Device
Coat-a-count(r) Estradiol-6
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K943193
Product code
CHP
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-23
Date received
1994-07-05
Regulation
862.1260
Classification name
Radioimmunoassay, Estradiol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KENNETH B ASARCH
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CHP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbH2004-09-24
K97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.1997-11-24
K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.1997-10-31
K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.1997-06-04
K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, Inc.1997-02-25
K965109ELECSYS ESTRADIOL ASSAYBoehringer Mannheim Corp.1997-02-18
K955647VIDAS ESTRADIOL II (E2II) ASSAYBiomerieux Vitek, Inc.1996-02-06
K954697CIBA CORNING ACS ESTRADIOL-6 ASSAYCiba Corning Diagnostics Corp.1995-12-13
K953605ULTRA-SENSITIVE ESTRADIOLDiagnostic Systems Laboratories, Inc.1995-10-02
K951360ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEMBayer Corp.1995-05-02
K946199AURAFLEX(R) ESTRADIOLOrganon Teknika Corp.1995-04-03
K941168CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KITIncstar Corp.1994-09-07
K932926IMMULITE ESTRADIOLDiagnostic Products Corp.1994-01-10
K932715CIBA CORNING ACS ESTRADIOL IMMUNOASSAYCiba Corning Diagnostics Corp.1993-12-03