JLS · Class I · 21 CFR 862.1620

FDA Product Code JLS: Radioimmunoassay, Progesterone

Leading manufacturers include Diagnostic Products Corp., Amersham Corp. and Boehringer Mannheim Corp..

57
Total
57
Cleared
59d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Progesterone Devices (Product Code JLS)

57 devices
1–24 of 57
Cleared Jun 24, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 18d
Cleared Jun 18, 1997
OPUS PROGESTERONE
K971725
Behring Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
K964841
Boehringer Mannheim Corp.
Chemistry · 111d
Cleared Jan 09, 1997
VIDAS PROESTERONE (PRG) (30 409)
K965084
bioMerieux, Inc.
Chemistry · 21d
Cleared Mar 07, 1996
AXSYM PROGESTERONE
K955025
Abbott Laboratories
Chemistry · 126d
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769
Bio-Rad Laboratories, Inc.
Chemistry · 46d
Cleared Jun 13, 1995
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
K952075
Bayer Corp.
Chemistry · 41d
Cleared May 08, 1995
AURAFLEX PROGESTERONE 150TEST PACK
K951630
Organon Teknika Corp.
Chemistry · 31d
Cleared Apr 11, 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570
Baxter Diagnostics, Inc.
Chemistry · 67d
Cleared Dec 19, 1994
IMMULITE PROGESTERONE
K944211
Diagnostic Products Corp.
Chemistry · 112d
Cleared Jan 11, 1994
IMMULITE PROGESTERONE
K935138
Diagnostic Products Corp.
Chemistry · 75d
Cleared Nov 05, 1993
SYNELISA PROGESTERONE
K933128
Elias U.S.A., Inc.
Chemistry · 130d
Cleared Oct 22, 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228
Immunotech Corp.
Chemistry · 226d
Cleared Oct 22, 1993
AIA-PACK(R) PROG ASSAY
K933269
Tosoh Medics, Inc.
Chemistry · 108d
Cleared Oct 08, 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
K933635
Baxter Diagnostics, Inc.
Chemistry · 73d
Cleared Aug 02, 1993
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
K932955
Ciba Corning Diagnostics Corp.
Chemistry · 46d
Cleared Feb 18, 1992
AFFINITY PRG
K920230
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 32d
Cleared May 22, 1991
MILENIA PROGESTERONE
K911512
Diagnostic Products Corp.
Chemistry · 48d
Cleared Apr 08, 1991
ENZYMUN-TEST PROGESTERONE
K910683
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Feb 23, 1989
DELFIA PROGESTERONE KIT
K890428
Pharmacia, Inc.
Chemistry · 28d
Cleared Nov 10, 1988
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100
Amersham Corp.
Chemistry · 43d
Cleared Apr 18, 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934
Amersham Corp.
Chemistry · 42d
Cleared Feb 25, 1987
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855
Amersham Corp.
Chemistry · 76d
Cleared Jan 28, 1986
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d

About Product Code JLS - Regulatory Context