JLX · Class I · 21 CFR 862.1395

FDA Product Code JLX: Radioimmunoassay, 17-hydroxyprogesterone

Leading manufacturers include Wallac OY, Wien Laboratories, Inc. and Diagnostic Products Corp..

19
Total
19
Cleared
167d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, 17-hydroxyprogesterone Devices (Product Code JLX)

19 devices
1–19 of 19
Cleared Jul 23, 2010
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K100682
Wallac OY
Chemistry · 135d
Cleared Apr 16, 2009
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922
Wallac OY
Chemistry · 283d
Cleared Jan 29, 2008
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
K062534
Drg Intl., Inc.
Chemistry · 518d
Cleared Mar 13, 2007
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452
Neo-Genesis
Chemistry · 385d
Cleared Jul 11, 2005
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
K050960
Wallac OY
Chemistry · 84d
Cleared Sep 30, 2004
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042424
Wallac OY
Chemistry · 22d
Cleared Sep 30, 2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042425
Wallac OY
Chemistry · 22d
Cleared Feb 09, 1998
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350
Bio-Rad
Chemistry · 157d
Cleared Mar 30, 1995
ACCUSCREEN 17-HYDROXYPROGESTERONE
K934178
Neometrics, Inc.
Chemistry · 580d
Cleared Dec 28, 1994
NEOSCREEN ELISA HYDROXYPROGESTERONE
K940233
Pantex
Chemistry · 344d
Cleared Nov 10, 1994
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148
Diagnostic Systems Laboratories, Inc.
Chemistry · 133d
Cleared Jun 25, 1991
DELFIA(R) 17 -OH-PROGESTERON KIT
K912026
Pharmacia Diagnostics, Inc.
Hematology · 49d
Cleared Jun 18, 1991
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
K911839
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 54d
Cleared Sep 07, 1989
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Feb 23, 1989
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
K885198
Icn Biomedicals, Inc.
Chemistry · 69d
Cleared Feb 11, 1988
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782
Diagnostic Products Corp.
Chemistry · 84d
Cleared Apr 24, 1986
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335
Diagnostic Products Corp.
Chemistry · 85d
Cleared Feb 04, 1984
PROGESTERONE TEST SET 125I 17-OH
K834246
Wien Laboratories, Inc.
Chemistry · 59d
Cleared Oct 21, 1977
17-HYDROXYPROGESTERONE TEST SET
K771729
Wien Laboratories, Inc.
Chemistry · 37d

About Product Code JLX - Regulatory Context