The following data is part of a premarket notification filed by Immunex Radiochemical Diagnostics with the FDA for Human C-peptide Reagents.
| Device ID | K812288 |
| 510k Number | K812288 |
| Device Name: | HUMAN C-PEPTIDE REAGENTS |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | IMMUNEX RADIOCHEMICAL DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JKD |
| CFR Regulation Number | 862.1135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-13 |
| Decision Date | 1981-08-31 |