Olympus America, Inc. · Class I · Cleared Feb 8, 2002
| K-number | K014032 |
| Device name | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
| Applicant | Olympus America, Inc. |
| Product code | LBS |
| Device class | Class I |
| Decision date | Feb 8, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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