The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centria System 2 Automated Method/ria.
| Device ID | K801037 |
| 510k Number | K801037 |
| Device Name: | CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA |
| Classification | Automated Radioimmunoassay Systems, For Clinical Use |
| Applicant | UNION CARBIDE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCI |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-02 |
| Decision Date | 1980-05-28 |