The following data is part of a premarket notification filed by Clinical Diagnostics, Inc. with the FDA for Centrifichem Sys 400 Analyzer.
| Device ID | K771813 |
| 510k Number | K771813 |
| Device Name: | CENTRIFICHEM SYS 400 ANALYZER |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | CLINICAL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-27 |
| Decision Date | 1977-10-25 |