The following data is part of a premarket notification filed by Bio-rad with the FDA for Radias Automated Immunoassay System.
| Device ID | K930898 |
| 510k Number | K930898 |
| Device Name: | RADIAS AUTOMATED IMMUNOASSAY SYSTEM |
| Classification | Analyzer, Enzyme, For Clinical Use |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Trevor Wall |
| Correspondent | Trevor Wall BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JJI |
| CFR Regulation Number | 862.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1993-04-21 |