Coulter Electronics, Inc. · Class I · Cleared Dec 6, 1979
| K-number | K792319 |
| Device name | COULTER HDL CHOLESTEROL REAG. SYSTEM |
| Applicant | Coulter Electronics, Inc. |
| Product code | LBS |
| Device class | Class I |
| Decision date | Dec 6, 1979 |
| 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