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 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 Oct 09, 1987
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355
Medix Biotech, Inc.
Chemistry · 50d
Cleared Jan 21, 1987
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439
Beckman Instruments, Inc.
Chemistry · 70d
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 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
Cleared Jan 13, 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768
Terumo Medical Corp.
Chemistry · 47d
Cleared Nov 13, 1984
TANDEM - EPRL
K843804
Hybritech, Inc.
Chemistry · 47d
Cleared May 11, 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118
Abbott Laboratories
Chemistry · 57d
Cleared Jan 24, 1984
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925
Diagnostic Products Corp.
Chemistry · 71d
Cleared Oct 21, 1982
ABBOTT LABORATORIES PROLACTIN EIA
K822759
Abbott Laboratories
Chemistry · 37d
Cleared Jun 11, 1982
TANDEM PROLACTIN KIT
K821545
Hybritech, Inc.
Chemistry · 17d
Cleared May 24, 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 20d
Cleared Mar 26, 1982
CENTRIA PROLACTIN TEST SET
K813572
Ventrex Laboratories, Inc.
Chemistry · 94d
Cleared Jan 22, 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039
Leeco Diagnostics, Inc.
Chemistry · 15d
Cleared Jan 16, 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273
Corning Medical & Scientific
Chemistry · 18d
Cleared Jul 08, 1980
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020
Travenol Laboratories, S.A.
Chemistry · 69d