JLX · Class I · 21 CFR 862.1395

FDA Product Code JLX: Radioimmunoassay, 17-hydroxyprogesterone

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

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 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 Nov 10, 1994
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148
Diagnostic Systems Laboratories, Inc.
Chemistry · 133d
Cleared Sep 07, 1989
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
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

About Product Code JLX - Regulatory Context