FDA 510(k) Applications for Medical Device Product Code "JLS"
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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 |