CFT · Class I · 21 CFR 862.1625

FDA Product Code CFT: Radioimmunoassay, Prolactin (lactogen)

Leading manufacturers include Diagnostic Products Corp., Abbott Laboratories and Hybritech, Inc..

80
Total
80
Cleared
59d
Avg days
1979
Since
80 devices
25–48 of 80
Cleared Nov 07, 1990
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714
Ciba Corning Diagnostics Corp.
Chemistry · 20d
Cleared Nov 05, 1990
ELEGANCE PROLACTIN ELISA
K904483
Bioclone Australia Pty , Ltd.
Chemistry · 34d
Cleared Oct 12, 1990
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
K904458
London Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 19, 1990
AFFINITY PROLACTIN TEST SYSTEM
K902698
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 30d
Cleared Jun 12, 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673
Baxter Healthcare Corp
Chemistry · 63d
Cleared Apr 19, 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578
Diagnostic Products Corp.
Chemistry · 15d
Cleared Mar 30, 1990
ENZYMUN TEST(R) PROLACTIN
K900695
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Jan 19, 1990
ABBOTT IMX PROLACTIN
K896162
Abbott Laboratories
Chemistry · 87d
Cleared Dec 27, 1989
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641
Medix Biotech, Inc.
Chemistry · 33d
Cleared Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K895380
Serono-Baker Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Sep 18, 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003
Diagnostic Products Corp.
Chemistry · 41d
Cleared Nov 01, 1988
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747
Diagnostic Products Corp.
Chemistry · 61d
Cleared Nov 01, 1988
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878
Amersham Corp.
Chemistry · 49d
Cleared Sep 13, 1988
PRL-QUANT
K883269
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Jun 08, 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 43d
Cleared Mar 24, 1988
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
K880296
London Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 01, 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218
Binax, Inc.
Chemistry · 41d
Cleared Jan 11, 1988
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K874621
Cyberfluor, Inc.
Chemistry · 62d
Cleared Oct 09, 1987
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355
Medix Biotech, Inc.
Chemistry · 50d
Cleared Sep 25, 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400
Serono Diagnostics, Inc.
Chemistry · 32d
Cleared Sep 18, 1987
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
K872862
Serono Diagnostics, Inc.
Chemistry · 59d
Cleared May 14, 1987
HPROLACTIN KIT
K871542
Immuchem Corp.
Chemistry · 24d
Cleared Jan 21, 1987
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439
Beckman Instruments, Inc.
Chemistry · 70d