CFL · Radioimmunoassay, Human Growth Hormone
Clinical Chemistry · 21 CFR 862.1370 · Class 1
Overview
| Product Code | CFL |
|---|---|
| Device Name | Radioimmunoassay, Human Growth Hormone |
| Regulation | 21 CFR 862.1370 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | Sealite Sciences, Inc. | Sep 25, 1997 | SESE |
| K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | May 12, 1997 | SESE |
| K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | Diagnostic Systems Laboratories, Inc. | Apr 2, 1997 | SESE |
| K962758 | DSL 9100 IGF-II IRMA | Diagnostic Systems Laboratories, Inc. | Aug 30, 1996 | SESE |
| K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT | Nichols Institute Diagnostics | Jul 8, 1996 | SESE |
| K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA | Diagnostic Systems Laboratories, Inc. | Apr 23, 1996 | SESE |
| K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA | Diagnostic Systems Laboratories, Inc. | Mar 6, 1996 | SESE |
| K955376 | IMMULITE HGH | Diagnostic Products Corp. | Feb 16, 1996 | SESE |
| K955390 | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY | Corning Nichols Diagnostics | Dec 29, 1995 | SESE |
| K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) | Nichols Institute | Jul 3, 1995 | SESE |
| K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 | Nichols Institute | Jun 23, 1995 | SESE |
| K951752 | ACTIVE IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | May 10, 1995 | SESE |
| K951707 | DSL ACTIVE IFGBP-3 ELISA | Diagnostic Systems Laboratories, Inc. | May 10, 1995 | SESE |
| K950510 | OCTEIA IGF-1 KIT | Immunodiagnostic Systems , Ltd. | Apr 5, 1995 | SESE |
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) | Diagnostic Systems Laboratories, Inc. | Feb 22, 1995 | SESE |
| K930047 | DSL IGFBP-3 RIA (DSL 6700) | Diagnostic Systems Laboratories, Inc. | Jul 6, 1994 | SESE |
| K921868 | ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT | Endocrine Sciences Products | Jan 3, 1994 | SESE |
| K930484 | DELFIA(R) HGH KIT | Wallac OY | May 11, 1993 | SESE |
| K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Mar 4, 1992 | SESE |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | London Diagnostics, Inc. | Jul 30, 1991 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 10 clearances
- Nichols Institute Diagnostics — 4 clearances
- Diagnostic Products Corp. — 2 clearances
- Immuno Nuclear Corp. — 2 clearances
- Medix Biotech, Inc. — 2 clearances
