Ria Sys. for Human Growth Hormone
FDA 510(k) K780347 · Calbiochem-Behring Corp.
510(k) numberK780347
Submission
- Device name
- Ria Sys. for Human Growth Hormone
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- March 2, 1978
- Decision date
- April 12, 1978
- 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 |
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| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Ria Sys. for Human Growth Hormone cleared by the FDA?
Ria Sys. for Human Growth Hormone (K780347) received a 510(k) decision of Substantially Equivalent on April 12, 1978, 41 days after the submission was received.
What is the product code of K780347?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.