Immulite C-Peptide
FDA 510(k) K943767 · Diagnostic Products Corp.
510(k) numberK943767
Submission
- Device name
- Immulite C-Peptide
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- August 2, 1994
- Decision date
- March 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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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| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
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| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
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Questions and answers
When was Immulite C-Peptide cleared by the FDA?
Immulite C-Peptide (K943767) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 233 days after the submission was received.
What is the product code of K943767?
The FDA product code is JKD – Radioimmunoassay, C-Peptides Of Proinsulin, a Class I (low risk) device regulated under 21 CFR 862.1135.