Atlas FDA

CFL

36 FDA 510(k) clearances · Product code

42 daysmedian time to decision
192 days90th percentile
36clearances measured

FDA profile

Official device name
Radioimmunoassay, Human Growth Hormone
Device class
Class I (low risk)
Regulation
21 CFR 862.1370
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2012: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (K972761)Sealite Sciences, Inc.1997-09-25
DSL ACTIVE NON-EXTRACTION IGF-I ELISA (K971353)Diagnostic Systems Laboratories, Inc.1997-05-12
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701)Diagnostic Systems Laboratories, Inc.1997-04-02
DSL 9100 IGF-II IRMA (K962758)Diagnostic Systems Laboratories, Inc.1996-08-30
HUMAN GROWTH HORMONE IMMUNOASSAY KIT (K961678)Nichols Institute Diagnostics1996-07-08
DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172)Diagnostic Systems Laboratories, Inc.1996-04-23
DSL ACTIVE HUMAN GROWTH HORMONE ELISA (K960551)Diagnostic Systems Laboratories, Inc.1996-03-06
IMMULITE HGH (K955376)Diagnostic Products Corp.1996-02-16
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)Corning Nichols Diagnostics1995-12-29
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (K952505)Nichols Institute1995-07-03
IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (K946247)Nichols Institute1995-06-23
ACTIVE IGF-I ELISA (K951752)Diagnostic Systems Laboratories, Inc.1995-05-10
DSL ACTIVE IFGBP-3 ELISA (K951707)Diagnostic Systems Laboratories, Inc.1995-05-10
OCTEIA IGF-1 KIT (K950510)Immunodiagnostic Systems , Ltd.1995-04-05
DSL ACTIVE IGFBP-3 IRMA (DSL 6600) (K950228)Diagnostic Systems Laboratories, Inc.1995-02-22
DSL IGFBP-3 RIA (DSL 6700) (K930047)Diagnostic Systems Laboratories, Inc.1994-07-06
ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT (K921868)Endocrine Sciences Products1994-01-03
DELFIA(R) HGH KIT (K930484)Wallac OY1993-05-11
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT (K920299)Medix Biotech, Inc.1992-03-04
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (K912858)London Diagnostics, Inc.1991-07-30
AIA-PACK HGH (K905757)Tosoh Medics, Inc.1991-01-25
ELEGANCE GH ELISA (K905098)Bioclone Australia Pty , Ltd.1990-12-06
IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I (K896808)Nichols Institute Diagnostics1990-01-19
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 (K896643)Medix Biotech, Inc.1989-12-29
FIAGEN HGH FLUOROIMMUNOASSAY KIT (K882823)Cyberfluor, Inc.1988-08-30
DSL SOMATOMEDIN-C (DSL #5600) (K875229)Diagnostic Systems Laboratories, Inc.1988-07-01
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA (K860228)Boots-Celltech Diagnostics, Inc.1986-02-28
TERUMO SENSIBEAD EIA HGH KIT (K852299)Terumo Medical Corp.1985-07-09
SOMATOMEDIN C BY RADIOIMMUNOASSAY (K850892)Immuno Nuclear Corp.1985-06-06
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT (K851259)Nichols Institute Diagnostics1985-05-13
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT (K841088)Nichols Institute Diagnostics1984-10-22
HUMAN GROWTH HORMONE RIA KIT (K841094)Diagnostic Products Corp.1984-05-07
DAC-CEL HCG-MCA KIT RD52 (K831073)Wellcome Diagnostics1983-09-01
TANDEM - HGH KIT (K821366)Hybritech, Inc.1982-06-10
HUMAN GROWTH HORMONE-RADIOIMM. KIT (K803280)Immuno Nuclear Corp.1981-01-16
RIA SYS. FOR HUMAN GROWTH HORMONE (K780347)Calbiochem-Behring Corp.1978-04-12

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Every clearance here is in the API, with alerts when new ones post.