The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Au5800(r) Chemistry Analyzer.
| Device ID | K112412 |
| 510k Number | K112412 |
| Device Name: | AU5800(R) CHEMISTRY ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Contact | David G Davis |
| Correspondent | David G Davis BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987666543023 | K112412 | 000 |
| 14987666543016 | K112412 | 000 |