The following data is part of a premarket notification filed by Bio-rad with the FDA for Bio-rad Clinical Data Management System.
| Device ID | K942451 |
| 510k Number | K942451 |
| Device Name: | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM |
| Classification | Instrumentation, High Pressure Liquid Chromatography |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | John Nelson |
| Correspondent | John Nelson BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | LDM |
| Subsequent Product Code | CHQ |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1994-11-10 |