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CHP — Radioimmunoassay, Estradiol Class I

FDA Device Classification

Classification Details

Product Code
CHP
Device Class
Class I
Regulation Number
862.1260
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K041349iblLUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMSeptember 24, 2004
K973901kmi diagnostics17 B-ESTRADIOL (ELISA)November 24, 1997
K973743beckman instrumentsACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZEROctober 31, 1997
K970386chiron diagnosticsACS ESTADIOL-6 IIJune 4, 1997
K970643johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CAMarch 18, 1997
K970126bio-rad laboratoriesACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)February 25, 1997
K965109boehringer mannheimELECSYS ESTRADIOL ASSAYFebruary 18, 1997
K955647biomerieux vitekVIDAS ESTRADIOL II (E2II) ASSAYFebruary 6, 1996
K954697ciba corning diagnosticsCIBA CORNING ACS ESTRADIOL-6 ASSAYDecember 13, 1995
K953605diagnostic systems laboratoriesULTRA-SENSITIVE ESTRADIOLOctober 2, 1995
K951360bayerESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMay 2, 1995
K946199organon teknikaAURAFLEX(R) ESTRADIOLApril 3, 1995
K943193diagnostic productsCOAT-A-COUNT(R) ESTRADIOL-6February 23, 1995
K941168incstarCLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KITSeptember 7, 1994
K932926diagnostic productsIMMULITE ESTRADIOLJanuary 10, 1994
K932715ciba corning diagnosticsCIBA CORNING ACS ESTRADIOL IMMUNOASSAYDecember 3, 1993
K932084tosoh medicsAIA-PACK E2 ASSAYNovember 9, 1993
K933464baxter diagnosticsSTRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAYOctober 22, 1993
K933066pb diagnostic systemsOPUS ESTRADIOLSeptember 8, 1993
K931740bio-radCOTUBE ESTRADIOL RADIOIMMUNOASSAYAugust 16, 1993