The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Dacos Or Dacos Xl Clinical Chemistry Analyzer.
| Device ID | K884378 |
| 510k Number | K884378 |
| Device Name: | DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1989-02-27 |