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

FDA 510(k) Cleared Radioimmunoassay, Prolactin (lactogen) Devices (Product Code CFT)

80 devices
1–24 of 80
Cleared Feb 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 32d
Cleared Jan 21, 1997
ELECSYS PROLACTIN ASSAY
K964748
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Apr 26, 1996
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Feb 29, 1996
DSL ACTIVE PROLACTIN IRMA
K960060
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared Oct 20, 1995
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680
Bio-Rad Laboratories, Inc.
Chemistry · 18d
Cleared Mar 21, 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698
Organon Teknika Corp.
Chemistry · 179d
Cleared Nov 02, 1994
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811
Biomerieux Vitek, Inc.
Chemistry · 89d
Cleared Jun 21, 1994
AXSYM PROLACTIN
K935675
Abbott Laboratories
Chemistry · 207d
Cleared Jun 02, 1994
ACCESS PROLACTIN
K941175
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Aug 19, 1993
COBAS CORE PROLACTIN EIA
K930305
Roche Diagnostic Systems, Inc.
Chemistry · 210d
Cleared Mar 29, 1993
VISTA PROLACTIN ASSAY
K926386
Syva Co.
Chemistry · 97d
Cleared Mar 05, 1993
IMMULITE PROLACTIN
K925846
Diagnostic Products Corp.
Chemistry · 107d
Cleared Sep 02, 1992
AMERLITE PROLACTIN-30 ASSAY
K922170
Eastman Kodak Company
Chemistry · 117d
Cleared Mar 18, 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345
Medix Biotech, Inc.
Chemistry · 51d
Cleared Feb 18, 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135
Amersham Corp.
Chemistry · 155d
Cleared Aug 16, 1991
OPUS(R) PROLACTIN TEST SYSTEM
K913280
Pb Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Nov 07, 1990
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714
Ciba Corning Diagnostics Corp.
Chemistry · 20d
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 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988
Ciba Corning Diagnostics Corp.
Chemistry · 65d

About Product Code CFT - Regulatory Context