The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centrifichem Comb. Serum-based Calib..
| Device ID | K802741 |
| 510k Number | K802741 |
| Device Name: | CENTRIFICHEM COMB. SERUM-BASED CALIB. |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-03 |
| Decision Date | 1980-12-10 |