Elegance GH Elisa
FDA 510(k) K905098 · Bioclone Australia Pty , Ltd.
510(k) numberK905098
Submission
- Device name
- Elegance GH Elisa
- Applicant
- Bioclone Australia Pty , Ltd.
Washington, DC, US - Received
- November 13, 1990
- Decision date
- December 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFL – Radioimmunoassay, Human Growth Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1370
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972761 | Sealite Sciences, Inc. Aqualite Human Growth Hormone AssayCFL · Traditional | Sealite Sciences, Inc. | 09/25/1997SE |
| K971353 | DSL Active Non-Extraction Igf-I ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 05/12/1997SE |
| K970701 | DSL 1900 Active Human Growth Hormone Irma (DSL 1900)CFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/02/1997SE |
| K962758 | DSL 9100 Igf-Ii IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 08/30/1996SE |
| K961678 | Human Growth Hormone Immunoassay KitCFL · Traditional | Nichols Institute Diagnostics | 07/08/1996SE |
| K961172 | DSL Active Non-Extraction Igf-I IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/23/1996SE |
| K960551 | DSL Active Human Growth Hormone ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 03/06/1996SE |
| K955376 | Immulite HGHCFL · Traditional | Diagnostic Products Corp. | 02/16/1996SE |
| K955390 | Insulin-Like Growth Factor-I (Igf-I) Immunoradiometric AssayCFL · Traditional | Corning Nichols Diagnostics | 12/29/1995SE |
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)CFL · Traditional | Nichols Institute | 07/03/1995SE |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K935049 | Elegance Neonatal TSH ElisaJLW · Traditional | 10/03/1994SE |
| K922284 | Elegance FT4 ElisaCEC · Traditional | 07/10/1992SE |
| K910419 | Bioclone's Elegance Ige Elisa KitDGC · Traditional | 06/21/1991SE |
| K910420 | Bioclone's Elegance HCG Elisa KitJHI · Traditional | 02/26/1991SE |
| K905099 | Elegance TSH ElisaJLW · Traditional | 12/18/1990SE |
| K904822 | Elegance Ferritin ElisaDBF · Traditional | 11/29/1990SE |
| K904387 | Bioclones Elegance LH Elisa KitCEP · Traditional | 11/06/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | 11/05/1990SE |
| K904405 | Bioclones Elegance FSH Elisa KitCGJ · Traditional | 10/26/1990SE |
Questions and answers
When was Elegance GH Elisa cleared by the FDA?
Elegance GH Elisa (K905098) received a 510(k) decision of Substantially Equivalent on December 6, 1990, 23 days after the submission was received.
What is the product code of K905098?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.