The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for C-peptide Radioimmunoassay Test Kit.
| Device ID | K833396 |
| 510k Number | K833396 |
| Device Name: | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | SERONO DIAGNOSTICS, INC. 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 | 1983-09-30 |
| Decision Date | 1984-04-13 |