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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)
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Top companies in CFL

DateFirm and productCodeLinked 510(k)
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
Terminated
CFLNone listed
Sep 16, 2016Siemens Healthcare Diagnostics, Inc.
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Terminated
CFLNone listed
May 11, 2011Beckman Coulter Inc.
IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.
Terminated
CFLK951707
Sep 28, 2010Beckman Coulter Inc.
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in seru
Terminated
CFLK950228
Jun 4, 2005Nichols Institute Diagnostics
Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)
Terminated
CFLNone listed

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