Human C-Peptide Reagents
FDA 510(k) K812288 · Immunex Radiochemical Diagnostics
510(k) numberK812288
Submission
- Device name
- Human C-Peptide Reagents
- Applicant
- Immunex Radiochemical Diagnostics
Walker, MI, US - Received
- August 13, 1981
- Decision date
- August 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKD – Radioimmunoassay, C-Peptides Of Proinsulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1135
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951848 | Aia-Pack CPR AssayJKD · Traditional | Tosoh Medics, Inc. | 02/13/1996SE |
| K943767 | Immulite C-PeptideJKD · Traditional | Diagnostic Products Corp. | 03/23/1995SE |
| K896420 | DSL C-Peptide Ria (DSL #7000)JKD · Traditional | Diagnostic Systems Laboratories, Inc. | 05/24/1990SE |
| K854066 | Double Antibody C-Peptide Ria KitJKD · Traditional | Diagnostic Products Corp. | 11/12/1985SE |
| K842267 | C-PEP-RIA-100JKD · Traditional | Institut National Des Radioelements | 09/06/1984SE |
| K833396 | C-Peptide Radioimmunoassay Test KitJKD · Traditional | Serono Diagnostics, Inc. | 04/13/1984SE |
| K820666 | Human C-Peptide of Insulin by Radioimm.JKD · Traditional | Immuno Nuclear Corp. | 07/13/1982SE |
| K812689 | Ria Quant C-Peptide KitJKD · Traditional | Mallinckrodt Critical Care | 10/06/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | Calbiochem-Behring Corp. | 03/31/1981SE |
Questions and answers
When was Human C-Peptide Reagents cleared by the FDA?
Human C-Peptide Reagents (K812288) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 18 days after the submission was received.
What is the product code of K812288?
The FDA product code is JKD – Radioimmunoassay, C-Peptides Of Proinsulin, a Class I (low risk) device regulated under 21 CFR 862.1135.