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JLS — Radioimmunoassay, Progesterone Class I

FDA Device Classification

Classification Details

Product Code
JLS
Device Class
Class I
Regulation Number
862.1620
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040923iblLUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAJuly 22, 2004
K973898kmi diagnosticsPROGESTERONE ELISANovember 13, 1997
K972133johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTEJune 24, 1997
K971725behring diagnosticsOPUS PROGESTERONEJune 18, 1997
K964841boehringer mannheimELECSYS PROGESTERONE ASSAYMarch 24, 1997
K965084biomerieuxVIDAS PROESTERONE (PRG) (30 409)January 9, 1997
K955025abbott laboratoriesAXSYM PROGESTERONEMarch 7, 1996
K955769bio-rad laboratoriesACCESS PROGESTERONE ASSAYFebruary 5, 1996
K952075bayerPROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEMJune 13, 1995
K951630organon teknikaAURAFLEX PROGESTERONE 150TEST PACKMay 8, 1995
K950570baxter diagnosticsSTRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYApril 11, 1995
K944211diagnostic productsIMMULITE PROGESTERONEDecember 19, 1994
K935138diagnostic productsIMMULITE PROGESTERONEJanuary 11, 1994
K933128elias u.s.aSYNELISA PROGESTERONENovember 5, 1993
K933269tosoh medicsAIA-PACK(R) PROG ASSAYOctober 22, 1993
K931228immunotechPROGESTERONE RADIOIMMUNOASSAY KITOctober 22, 1993
K933635baxter diagnosticsSTRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAYOctober 8, 1993
K932955ciba corning diagnosticsCIBA CORNING ACS PROGESTERONE IMMUNOASSAYAugust 2, 1993
K923410cyberfluorFIAGEN PROGESTERONEDecember 3, 1992
K920230bd becton dickinson vacutainer systems preanalyticAFFINITY PRGFebruary 18, 1992