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 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 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
Cleared Dec 16, 1986
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE
K864075
United Biotech, Inc.
Chemistry · 57d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860
Hybritech, Inc.
Chemistry · 49d
Cleared Sep 29, 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240
Abbott Laboratories
Chemistry · 38d
Cleared Jun 27, 1986
SUCROSEP HUMAN PROLACTIN (HPR) IRMA
K861271
Boots-Celltech Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 17, 1986
DELFIA (TM) HUMAN PROLACTIN
K861542
Lkb Instruments, Inc.
Chemistry · 54d
Cleared Jun 13, 1986
LEE-BEAD PROLACTIN (EIA)
K861945
Leeco Diagnostics, Inc.
Chemistry · 24d
Cleared Mar 05, 1986
ENCORE PROLACTIN REAGENT
K860221
Hybritech, Inc.
Chemistry · 42d
Cleared Jan 28, 1986
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
K854805
Nichols Institute Diagnostics
Chemistry · 57d