The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite C-peptide.
| Device ID | K943767 |
| 510k Number | K943767 |
| Device Name: | IMMULITE C-PEPTIDE |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch, Pharm.d., Ph.d. |
| Correspondent | Kenneth B Asarch, Pharm.d., Ph.d. 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 | 1994-08-02 |
| Decision Date | 1995-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414953656 | K943767 | 000 |
| 00630414953007 | K943767 | 000 |