Atlas FDA

JLX

19 FDA 510(k) clearances · Product code

84 daysmedian time to decision
518 days90th percentile
19clearances measured

FDA profile

Official device name
Radioimmunoassay, 17-Hydroxyprogesterone
Device class
Class I (low risk)
Regulation
21 CFR 862.1395
Medical specialty
Clinical Chemistry
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RecordFirmDate
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (K100682)Wallac OY2010-07-23
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K081922)Wallac OY2009-04-16
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (K062534)Drg Intl., Inc.2008-01-29
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (K060452)Neo-Genesis2007-03-13
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (K050960)Wallac OY2005-07-11
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042424)Wallac OY2004-09-30
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042425)Wallac OY2004-09-30
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (K973350)Bio-Rad1998-02-09
ACCUSCREEN 17-HYDROXYPROGESTERONE (K934178)Neometrics, Inc.1995-03-30
NEOSCREEN ELISA HYDROXYPROGESTERONE (K940233)Pantex1994-12-28
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (K943148)Diagnostic Systems Laboratories, Inc.1994-11-10
DELFIA(R) 17 -OH-PROGESTERON KIT (K912026)Pharmacia Diagnostics, Inc.1991-06-25
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (K911839)Pantex, Div. Bio-Analysis, Inc.1991-06-18
DSL 17A-OH PROGERSTERONE (DSL #6800) (K894265)Diagnostic Systems Laboratories, Inc.1989-09-07
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (K885198)Icn Biomedicals, Inc.1989-02-23
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT (K874782)Diagnostic Products Corp.1988-02-11
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT (K860335)Diagnostic Products Corp.1986-04-24
PROGESTERONE TEST SET 125I 17-OH (K834246)Wien Laboratories, Inc.1984-02-04
17-HYDROXYPROGESTERONE TEST SET (K771729)Wien Laboratories, Inc.1977-10-21

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Every clearance here is in the API, with alerts when new ones post.