Product code CFL
- Device name
- Radioimmunoassay, Human Growth Hormone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1370
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | Sealite Sciences, Inc. | 1997-09-25 |
| K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1997-05-12 |
| K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | Diagnostic Systems Laboratories, Inc. | 1997-04-02 |
| K962758 | DSL 9100 IGF-II IRMA | Diagnostic Systems Laboratories, Inc. | 1996-08-30 |
| K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT | Nichols Institute Diagnostics | 1996-07-08 |
| K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-23 |
| K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 |
| K955376 | IMMULITE HGH | Diagnostic Products Corp. | 1996-02-16 |
| K955390 | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY | Corning Nichols Diagnostics | 1995-12-29 |
| K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) | Nichols Institute | 1995-07-03 |
| K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 | Nichols Institute | 1995-06-23 |
| K951752 | ACTIVE IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 |
| K951707 | DSL ACTIVE IFGBP-3 ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 |
| K950510 | OCTEIA IGF-1 KIT | Immunodiagnostic Systems , Ltd. | 1995-04-05 |
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) | Diagnostic Systems Laboratories, Inc. | 1995-02-22 |
| K930047 | DSL IGFBP-3 RIA (DSL 6700) | Diagnostic Systems Laboratories, Inc. | 1994-07-06 |
| K921868 | ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT | Endocrine Sciences Products | 1994-01-03 |
| K930484 | DELFIA(R) HGH KIT | Wallac OY | 1993-05-11 |
| K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-04 |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | London Diagnostics, Inc. | 1991-07-30 |
| K905757 | AIA-PACK HGH | Tosoh Medics, Inc. | 1991-01-25 |
| K905098 | ELEGANCE GH ELISA | Bioclone Australia Pty , Ltd. | 1990-12-06 |
| K896808 | IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I | Nichols Institute Diagnostics | 1990-01-19 |
| K896643 | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 | Medix Biotech, Inc. | 1989-12-29 |
| K882823 | FIAGEN HGH FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1988-08-30 |
| K875229 | DSL SOMATOMEDIN-C (DSL #5600) | Diagnostic Systems Laboratories, Inc. | 1988-07-01 |
| K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-02-28 |
| K852299 | TERUMO SENSIBEAD EIA HGH KIT | Terumo Medical Corp. | 1985-07-09 |
| K850892 | SOMATOMEDIN C BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-06-06 |
| K851259 | HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT | Nichols Institute Diagnostics | 1985-05-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850049545815 | AccuDiag™ Human Growth Hormone (HGH) ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| B24211HGHHUE010 | Human Growth Hormone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2025-01-20 |
| 04048474018646 | TGF-Beta 1 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 04048474023961 | TGF-Beta 2 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 00816870024813 | IGF-1 AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024820 | IGF-1 AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024882 | IGF-1 AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024899 | IGF-1 AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474041408 | IGF-1 600 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474017878 | Human Growth Hormone (HGH) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-26 |
| 00840239041401 | IGF-1 600 ELISA | DRG International Inc | 2023-08-25 |
| 00840239035523 | HGH (Human Growth Hormone) ELISA | DRG International Inc | 2023-08-24 |
| 00840239023964 | TGF-B2 ELISA | DRG International Inc | 2023-08-23 |
| 00840239018649 | TGF-B1 ELISA | DRG International Inc | 2023-08-23 |
| B261CANGH40700 | DBC Growth Hormone (GH) ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| 06925912719281 | iFlash-hGH | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 03770024321562 | HGH-US | CISBIO BIOASSAYS | 2021-12-07 |
| 00404847441406 | IGF-1 600 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-11 |
| 00840239017871 | Human Growth Hormone (HGH) ELISA | DRG International Inc | 2021-06-09 |
| 00404847418644 | TGF-Beta 1 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847423969 | TGF-Beta 2 ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 04015630926664 | Elecsys hGH | Roche Diagnostics GmbH | 2021-01-18 |
| 00630414601236 | IMMULITE® 2000 Systems IGF-I | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 14560189211442 | AIA-PACK HGH Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 14560189211435 | AIA-PACK HGH Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 24560189210459 | ST AIA-PACK HGH | TOSOH CORPORATION | 2019-07-24 |
| 04560189211445 | AIA-PACK HGH Calibrator Set | TOSOH CORPORATION | 2019-07-24 |
| 04560189211438 | AIA-PACK HGH Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 14560189210452 | ST AIA-PACK HGH | TOSOH CORPORATION | 2019-07-24 |
| 04015630940424 | Elecsys hGH | Roche Diagnostics GmbH | 2017-05-10 |