JKD — Radioimmunoassay, C-Peptides Of Proinsulin Class I
FDA product code JKD covers "Radioimmunoassay, C-Peptides Of Proinsulin", a Class I medical device regulated under 21 CFR 862.1135. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JKD
- Device Class
- Class I
- Regulation Number
- 862.1135
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K951848 | tosoh medics | AIA-PACK CPR ASSAY | February 13, 1996 |
| K943767 | diagnostic products | IMMULITE C-PEPTIDE | March 23, 1995 |
| K896420 | diagnostic systems laboratories | DSL C-PEPTIDE RIA (DSL #7000) | May 24, 1990 |
| K854066 | diagnostic products | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | November 12, 1985 |
| K842267 | institut national des radioelements | C-PEP-RIA-100 | September 6, 1984 |
| K833396 | serono diagnostics | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | April 13, 1984 |
| K820666 | immuno nuclear | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | July 13, 1982 |
| K812689 | mallinckrodt critical care | RIA QUANT C-PEPTIDE KIT | October 6, 1981 |
| K812288 | immunex radiochemical diagnostics | HUMAN C-PEPTIDE REAGENTS | August 31, 1981 |
| K810718 | calbiochem-behring | C-PEPTICE REAGENTS | March 31, 1981 |