IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3
FDA 510(k) K946247 · Nichols Institute
510(k) numberK946247
Submission
- Device name
- IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3
- Applicant
- Nichols Institute
San Juan Capistrano, CA, US - Received
- December 22, 1994
- Decision date
- June 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K952559 | Erythropoietin Immunoassay KitGGT · Traditional | 05/29/1996SE |
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)CFL · Traditional | 07/03/1995SE |
| K950524 | Nichols Institute Diagnostics Dhea-S Chemiluminescence ImmunoassayJKC · Traditional | 05/15/1995SE |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | 03/11/1994SE |
| K931600 | Chemiluminescence Free T3 ImmunoassayCDP · Traditional | 09/08/1993SE |
| K931777 | Apo A-1 Chemiluminescence AssayMSJ · Traditional | 08/16/1993SE |
| K931601 | Chemiluminescence Dhea-S ImmunoassayJKC · Traditional | 07/27/1993SE |
| K926396 | Adrenocorticotropic/Acth Analysis ProductCKG · Traditional | 07/27/1993SE |
| K931311 | Thyroid Peroxidase Auto Antibodies(Tpo) Immun KitJZO · Traditional | 05/14/1993SE |
| K930777 | Thyroglobulin Autoantibody Immunoassay KitJNL · Traditional | 04/08/1993SE |
Questions and answers
When was IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3 cleared by the FDA?
IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3 (K946247) received a 510(k) decision of Substantially Equivalent on June 23, 1995, 183 days after the submission was received.
What is the product code of K946247?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.