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JLX — Radioimmunoassay, 17-Hydroxyprogesterone Class I

FDA Device Classification

Classification Details

Product Code
JLX
Device Class
Class I
Regulation Number
862.1395
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100682wallacGSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UJuly 23, 2010
K081922wallacAUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITApril 16, 2009
K062534drg intlENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJanuary 29, 2008
K060452neo-genesisACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAHMarch 13, 2007
K050960wallacMODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITJuly 11, 2005
K042424wallacDELFIA NEONATAL 17A-OH-PROGESTERONE KITSeptember 30, 2004
K042425wallacAUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITSeptember 30, 2004
K973350bio-radBIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TESTFebruary 9, 1998
K934178neometricsACCUSCREEN 17-HYDROXYPROGESTERONEMarch 30, 1995
K940233pantexNEOSCREEN ELISA HYDROXYPROGESTERONEDecember 28, 1994
K943148diagnostic systems laboratoriesDSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)November 10, 1994
K912026pharmacia diagnosticsDELFIA(R) 17 -OH-PROGESTERON KITJune 25, 1991
K911839pantex, div. bio-analysisNEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITJune 18, 1991
K894265diagnostic systems laboratoriesDSL 17A-OH PROGERSTERONE (DSL #6800)September 7, 1989
K885198icn biomedicals17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIAFebruary 23, 1989
K874782diagnostic productsCOAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KITFebruary 11, 1988
K860335diagnostic productsCOAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KITApril 24, 1986
K834246wien laboratoriesPROGESTERONE TEST SET 125I 17-OHFebruary 4, 1984
K771729wien laboratories17-HYDROXYPROGESTERONE TEST SETOctober 21, 1977