FDA Product Code CFL: Radioimmunoassay, Human Growth Hormone
Leading manufacturers include Diagnostic Systems Laboratories, Inc., Nichols Institute Diagnostics and Medix Biotech, Inc..
36
Total
36
Cleared
90d
Avg days
1978
Since
FDA 510(k) Cleared Radioimmunoassay, Human Growth Hormone Devices (Product Code CFL)
36 devices
Cleared
Sep 25, 1997
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
Sealite Sciences, Inc.
Chemistry
63d
Cleared
May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
Diagnostic Systems Laboratories, Inc.
Chemistry
31d
Cleared
Apr 02, 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
Diagnostic Systems Laboratories, Inc.
Chemistry
35d
Cleared
Aug 30, 1996
DSL 9100 IGF-II IRMA
Diagnostic Systems Laboratories, Inc.
Chemistry
45d
Cleared
Jul 08, 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
Nichols Institute Diagnostics
Chemistry
68d
Cleared
Apr 23, 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
Diagnostic Systems Laboratories, Inc.
Chemistry
29d
Cleared
Mar 06, 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
Diagnostic Systems Laboratories, Inc.
Chemistry
27d
Cleared
Feb 16, 1996
IMMULITE HGH
Diagnostic Products Corp.
Chemistry
84d
Cleared
May 10, 1995
DSL ACTIVE IFGBP-3 ELISA
Diagnostic Systems Laboratories, Inc.
Chemistry
27d
Cleared
May 10, 1995
ACTIVE IGF-I ELISA
Diagnostic Systems Laboratories, Inc.
Chemistry
23d
Cleared
Apr 05, 1995
OCTEIA IGF-1 KIT
Immunodiagnostic Systems , Ltd.
Chemistry
58d
Cleared
Feb 22, 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
Diagnostic Systems Laboratories, Inc.
Chemistry
42d
Cleared
Jul 06, 1994
DSL IGFBP-3 RIA (DSL 6700)
Diagnostic Systems Laboratories, Inc.
Chemistry
547d
Cleared
May 11, 1993
DELFIA(R) HGH KIT
Wallac OY
Chemistry
102d
Cleared
Mar 04, 1992
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
Medix Biotech, Inc.
Chemistry
42d
Cleared
Jan 25, 1991
AIA-PACK HGH
Tosoh Medics, Inc.
Chemistry
29d
Cleared
Jan 19, 1990
IGF-I BY EXTRACTION
Nichols Institute Diagnostics
Chemistry
46d
Cleared
Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
Medix Biotech, Inc.
Chemistry
35d
Cleared
Aug 30, 1988
FIAGEN HGH FLUOROIMMUNOASSAY KIT
Cyberfluor, Inc.
Chemistry
53d
Cleared
Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
Diagnostic Systems Laboratories, Inc.
Chemistry
192d
Cleared
Feb 28, 1986
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
Boots-Celltech Diagnostics, Inc.
Chemistry
37d
Cleared
Jul 09, 1985
TERUMO SENSIBEAD EIA HGH KIT
Terumo Medical Corp.
Chemistry
41d
Cleared
Jun 06, 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
Immuno Nuclear Corp.
Chemistry
94d
Cleared
May 13, 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
Nichols Institute Diagnostics
Chemistry
46d