The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for C-peptice Reagents.
| Device ID | K810718 |
| 510k Number | K810718 |
| Device Name: | C-PEPTICE REAGENTS |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKD |
| CFR Regulation Number | 862.1135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-03-31 |