Somatomedin C by Radioimmunoassay
FDA 510(k) K850892 · Immuno Nuclear Corp.
510(k) numberK850892
Submission
- Device name
- Somatomedin C by Radioimmunoassay
- Applicant
- Immuno Nuclear Corp.
Stillwater, MN, US - Received
- March 4, 1985
- Decision date
- June 6, 1985
- 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 |
|---|---|---|
| K863743 | Biotech's Ige Immuno Response Test Isotope UnitDHB · Traditional | 12/15/1986SE |
| K863973 | Elm Allergen DiscDHB · Traditional | 12/01/1986SE |
| K863844 | Immuno Biotech's Lamb's Quarters Allergen DiscDHB · Traditional | 10/29/1986SE |
| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
| K863098 | Meadow Fescue Allergen DiscDHB · Traditional | 09/15/1986SE |
| K862266 | Maple Allergen DiscDHB · Traditional | 08/19/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
Questions and answers
When was Somatomedin C by Radioimmunoassay cleared by the FDA?
Somatomedin C by Radioimmunoassay (K850892) received a 510(k) decision of Substantially Equivalent on June 6, 1985, 94 days after the submission was received.
What is the product code of K850892?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.