FDA 510(k) Applications for Medical Device Product Code "JLS"
(Radioimmunoassay, Progesterone)

FDA 510(k) Number Applicant Device Name Decision Date
K955025 ABBOTT LABORATORIES AXSYM PROGESTERONE 03/07/1996
K971725 BEHRING DIAGNOSTICS, INC. OPUS PROGESTERONE 06/18/1997
K955769 BIO-RAD LABORATORIES, INC. ACCESS PROGESTERONE ASSAY 02/05/1996
K965084 BIOMERIEUX, INC. VIDAS PROESTERONE (PRG) (30 409) 01/09/1997
K964841 BOEHRINGER MANNHEIM CORP. ELECSYS PROGESTERONE ASSAY 03/24/1997
K040923 IBL GMBH LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA 07/22/2004
K972133 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) 06/24/1997
K973898 KMI DIAGNOSTICS, INC. PROGESTERONE ELISA 11/13/1997


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