Olympus America, Inc. · Class II · Cleared Jun 6, 2006
| K-number | K060201 |
| Device name | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. |
| Applicant | Olympus America, Inc. |
| Product code | DHR |
| Device class | Class II |
| Decision date | Jun 6, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 866.5775 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov