CFL · Class I · 21 CFR 862.1370

FDA Product Code CFL: Radioimmunoassay, Human Growth Hormone

Leading manufacturers include Diagnostic Systems Laboratories, Inc., Nichols Institute Diagnostics and Immuno Nuclear Corp..

36
Total
36
Cleared
90d
Avg days
1978
Since

FDA 510(k) Cleared Radioimmunoassay, Human Growth Hormone Devices (Product Code CFL)

36 devices
1–24 of 36
Cleared May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Apr 02, 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701
Diagnostic Systems Laboratories, Inc.
Chemistry · 35d
Cleared Aug 30, 1996
DSL 9100 IGF-II IRMA
K962758
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Jul 08, 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
K961678
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Apr 23, 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d
Cleared Mar 06, 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
K960551
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared Feb 16, 1996
IMMULITE HGH
K955376
Diagnostic Products Corp.
Chemistry · 84d
Cleared May 10, 1995
DSL ACTIVE IFGBP-3 ELISA
K951707
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared May 10, 1995
ACTIVE IGF-I ELISA
K951752
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared Apr 05, 1995
OCTEIA IGF-1 KIT
K950510
Immunodiagnostic Systems , Ltd.
Chemistry · 58d
Cleared Feb 22, 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
K950228
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Jul 06, 1994
DSL IGFBP-3 RIA (DSL 6700)
K930047
Diagnostic Systems Laboratories, Inc.
Chemistry · 547d
Cleared Mar 04, 1992
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299
Medix Biotech, Inc.
Chemistry · 42d
Cleared Jan 25, 1991
AIA-PACK HGH
K905757
Tosoh Medics, Inc.
Chemistry · 29d
Cleared Jan 19, 1990
IGF-I BY EXTRACTION
K896808
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643
Medix Biotech, Inc.
Chemistry · 35d
Cleared Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229
Diagnostic Systems Laboratories, Inc.
Chemistry · 192d
Cleared Jul 09, 1985
TERUMO SENSIBEAD EIA HGH KIT
K852299
Terumo Medical Corp.
Chemistry · 41d
Cleared Jun 06, 1985
SOMATOMEDIN C BY RADIOIMMUNOASSAY
K850892
Immuno Nuclear Corp.
Chemistry · 94d
Cleared May 13, 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Oct 22, 1984
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088
Nichols Institute Diagnostics
Chemistry · 223d
Cleared May 07, 1984
HUMAN GROWTH HORMONE RIA KIT
K841094
Diagnostic Products Corp.
Chemistry · 55d
Cleared Sep 01, 1983
DAC-CEL HCG-MCA KIT RD52
K831073
Wellcome Diagnostics
Chemistry · 150d
Cleared Jun 10, 1982
TANDEM - HGH KIT
K821366
Hybritech, Inc.
Chemistry · 31d

About Product Code CFL - Regulatory Context