Panels › Clinical Chemistry › Product code CFL · Class 1
Radioimmunoassay, Human Growth Hormone
Regulation 862.1370
0510(k)s in 12 months (36 all time)
0recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in CFL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1997 | K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY Sealite Sciences, Inc. | CFL |
| May 12, 1997 | K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Apr 2, 1997 | K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) Diagnostic Systems Laboratories, Inc. | CFL |
| Aug 30, 1996 | K962758 | DSL 9100 IGF-II IRMA Diagnostic Systems Laboratories, Inc. | CFL |
| Jul 8, 1996 | K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT Nichols Institute Diagnostics | CFL |
| Apr 23, 1996 | K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA Diagnostic Systems Laboratories, Inc. | CFL |
| Mar 6, 1996 | K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Feb 16, 1996 | K955376 | IMMULITE HGH Diagnostic Products Corp. | CFL |
| Dec 29, 1995 | K955390 | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY Corning Nichols Diagnostics | CFL |
| Jul 3, 1995 | K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) Nichols Institute | CFL |
| Jun 23, 1995 | K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 Nichols Institute | CFL |
| May 10, 1995 | K951752 | ACTIVE IGF-I ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| May 10, 1995 | K951707 | DSL ACTIVE IFGBP-3 ELISA Diagnostic Systems Laboratories, Inc. | CFL |
| Apr 5, 1995 | K950510 | OCTEIA IGF-1 KIT Immunodiagnostic Systems , Ltd., GB | CFL |
| Feb 22, 1995 | K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) Diagnostic Systems Laboratories, Inc. | CFL |
| Jul 6, 1994 | K930047 | DSL IGFBP-3 RIA (DSL 6700) Diagnostic Systems Laboratories, Inc. | CFL |
| Jan 3, 1994 | K921868 | ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT Endocrine Sciences Products | CFL |
| May 11, 1993 | K930484 | DELFIA(R) HGH KIT Wallac OY, FI | CFL |
| Mar 4, 1992 | K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CFL |
| Jul 30, 1991 | K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY London Diagnostics, Inc. | CFL |
| Jan 25, 1991 | K905757 | AIA-PACK HGH Tosoh Medics, Inc. | CFL |
| Dec 6, 1990 | K905098 | ELEGANCE GH ELISA Bioclone Australia Pty , Ltd. | CFL |
| Jan 19, 1990 | K896808 | IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I Nichols Institute Diagnostics | CFL |
| Dec 29, 1989 | K896643 | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 Medix Biotech, Inc. | CFL |
| Aug 30, 1988 | K882823 | FIAGEN HGH FLUOROIMMUNOASSAY KIT Cyberfluor, Inc., CA | CFL |
| Jul 1, 1988 | K875229 | DSL SOMATOMEDIN-C (DSL #5600) Diagnostic Systems Laboratories, Inc. | CFL |
| Feb 28, 1986 | K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA Boots-Celltech Diagnostics, Inc., GB | CFL |
| Jul 9, 1985 | K852299 | TERUMO SENSIBEAD EIA HGH KIT Terumo Medical Corp. | CFL |
| Jun 6, 1985 | K850892 | SOMATOMEDIN C BY RADIOIMMUNOASSAY Immuno Nuclear Corp. | CFL |
| May 13, 1985 | K851259 | HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT Nichols Institute Diagnostics | CFL |
| Oct 22, 1984 | K841088 | SOMATOMEDIN-C RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics | CFL |
| May 7, 1984 | K841094 | HUMAN GROWTH HORMONE RIA KIT Diagnostic Products Corp. | CFL |
| Sep 1, 1983 | K831073 | DAC-CEL HCG-MCA KIT RD52 Wellcome Diagnostics | CFL |
| Jun 10, 1982 | K821366 | TANDEM - HGH KIT Hybritech, Inc. | CFL |
| Jan 16, 1981 | K803280 | HUMAN GROWTH HORMONE-RADIOIMM. KIT Immuno Nuclear Corp. | CFL |
| Apr 12, 1978 | K780347 | RIA SYS. FOR HUMAN GROWTH HORMONE Calbiochem-Behring Corp. | CFL |
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