The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Double Antibody C-peptide Ria Kit.
| Device ID | K854066 |
| 510k Number | K854066 |
| Device Name: | DOUBLE ANTIBODY C-PEPTIDE RIA KIT |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Sidney A Aroesty |
| Correspondent | Sidney A Aroesty DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JKD |
| CFR Regulation Number | 862.1135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-04 |
| Decision Date | 1985-11-12 |