FDA 510(k) Applications for Medical Device Product Code "CFL"
(Radioimmunoassay, Human Growth Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K905098 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE GH ELISA 12/06/1990
K860228 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA 02/28/1986
K780347 CALBIOCHEM-BEHRING CORP. RIA SYS. FOR HUMAN GROWTH HORMONE 04/12/1978
K955390 CORNING NICHOLS DIAGNOSTICS INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY 12/29/1995
K882823 CYBERFLUOR, INC. FIAGEN HGH FLUOROIMMUNOASSAY KIT 08/30/1988
K841094 DIAGNOSTIC PRODUCTS CORP. HUMAN GROWTH HORMONE RIA KIT 05/07/1984
K955376 DIAGNOSTIC PRODUCTS CORP. IMMULITE HGH 02/16/1996
K951752 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE IGF-I ELISA 05/10/1995
K970701 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) 04/02/1997
K962758 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 9100 IGF-II IRMA 08/30/1996
K960551 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE HUMAN GROWTH HORMONE ELISA 03/06/1996
K951707 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE IFGBP-3 ELISA 05/10/1995
K950228 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE IGFBP-3 IRMA (DSL 6600) 02/22/1995
K961172 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE NON-EXTRACTION IGF-I IRMA 04/23/1996
K971353 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE NON-EXTRACTION IGF-I ELISA 05/12/1997
K930047 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL IGFBP-3 RIA (DSL 6700) 07/06/1994
K875229 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL SOMATOMEDIN-C (DSL #5600) 07/01/1988
K921868 ENDOCRINE SCIENCES PRODUCTS ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT 01/03/1994
K821366 HYBRITECH, INC. TANDEM - HGH KIT 06/10/1982
K803280 IMMUNO NUCLEAR CORP. HUMAN GROWTH HORMONE-RADIOIMM. KIT 01/16/1981
K850892 IMMUNO NUCLEAR CORP. SOMATOMEDIN C BY RADIOIMMUNOASSAY 06/06/1985
K950510 IMMUNODIAGNOSTIC SYSTEMS LTD. OCTEIA IGF-1 KIT 04/05/1995
K912858 LONDON DIAGNOSTICS, INC. LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY 07/30/1991
K896643 MEDIX BIOTECH, INC. HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 12/29/1989
K920299 MEDIX BIOTECH, INC. MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT 03/04/1992
K946247 NICHOLS INSTITUTE IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 06/23/1995
K952505 NICHOLS INSTITUTE INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) 07/03/1995
K961678 NICHOLS INSTITUTE DIAGNOSTICS HUMAN GROWTH HORMONE IMMUNOASSAY KIT 07/08/1996
K851259 NICHOLS INSTITUTE DIAGNOSTICS HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT 05/13/1985
K896808 NICHOLS INSTITUTE DIAGNOSTICS IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I 01/19/1990
K841088 NICHOLS INSTITUTE DIAGNOSTICS SOMATOMEDIN-C RADIOIMMUNOASSAY KIT 10/22/1984
K972761 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY 09/25/1997
K852299 TERUMO MEDICAL CORP. TERUMO SENSIBEAD EIA HGH KIT 07/09/1985
K905757 TOSOH MEDICS, INC. AIA-PACK HGH 01/25/1991
K930484 WALLAC OY DELFIA(R) HGH KIT 05/11/1993
K831073 WELLCOME DIAGNOSTICS DAC-CEL HCG-MCA KIT RD52 09/01/1983


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