Human C-Peptide of Insulin by Radioimm.
FDA 510(k) K820666 · Immuno Nuclear Corp.
510(k) numberK820666
Submission
- Device name
- Human C-Peptide of Insulin by Radioimm.
- Applicant
- Immuno Nuclear Corp.
Mchenry, IL, US - Received
- March 11, 1982
- Decision date
- July 13, 1982
- 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 |
| K812689 | Ria Quant C-Peptide KitJKD · Traditional | Mallinckrodt Critical Care | 10/06/1981SE |
| K812288 | Human C-Peptide ReagentsJKD · Traditional | Immunex Radiochemical Diagnostics | 08/31/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | Calbiochem-Behring Corp. | 03/31/1981SE |
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| 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 |
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Questions and answers
When was Human C-Peptide of Insulin by Radioimm. cleared by the FDA?
Human C-Peptide of Insulin by Radioimm. (K820666) received a 510(k) decision of Substantially Equivalent on July 13, 1982, 124 days after the submission was received.
What is the product code of K820666?
The FDA product code is JKD – Radioimmunoassay, C-Peptides Of Proinsulin, a Class I (low risk) device regulated under 21 CFR 862.1135.