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CFL — Radioimmunoassay, Human Growth Hormone Class I

FDA Device Classification

Classification Details

Product Code
CFL
Device Class
Class I
Regulation Number
862.1370
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972761sealite sciencesSEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSeptember 25, 1997
K971353diagnostic systems laboratoriesDSL ACTIVE NON-EXTRACTION IGF-I ELISAMay 12, 1997
K970701diagnostic systems laboratoriesDSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)April 2, 1997
K962758diagnostic systems laboratoriesDSL 9100 IGF-II IRMAAugust 30, 1996
K961678nichols institute diagnosticsHUMAN GROWTH HORMONE IMMUNOASSAY KITJuly 8, 1996
K961172diagnostic systems laboratoriesDSL ACTIVE NON-EXTRACTION IGF-I IRMAApril 23, 1996
K960551diagnostic systems laboratoriesDSL ACTIVE HUMAN GROWTH HORMONE ELISAMarch 6, 1996
K955376diagnostic productsIMMULITE HGHFebruary 16, 1996
K955390corning nichols diagnosticsINSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAYDecember 29, 1995
K952505nichols instituteINSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)July 3, 1995
K946247nichols instituteIGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3June 23, 1995
K951752diagnostic systems laboratoriesACTIVE IGF-I ELISAMay 10, 1995
K951707diagnostic systems laboratoriesDSL ACTIVE IFGBP-3 ELISAMay 10, 1995
K950510immunodiagnostic systemsOCTEIA IGF-1 KITApril 5, 1995
K950228diagnostic systems laboratoriesDSL ACTIVE IGFBP-3 IRMA (DSL 6600)February 22, 1995
K930047diagnostic systems laboratoriesDSL IGFBP-3 RIA (DSL 6700)July 6, 1994
K921868endocrine sciences productsENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KITJanuary 3, 1994
K930484wallacDELFIA(R) HGH KITMay 11, 1993
K920299medix biotechMEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KITMarch 4, 1992
K912858london diagnosticsLONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAYJuly 30, 1991