International Enzymes, Inc. · Class II · Cleared Sep 15, 1995
| K-number | K953926 |
| Device name | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM |
| Applicant | International Enzymes, Inc. |
| Product code | DCK |
| Device class | Class II |
| Decision date | Sep 15, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 866.5270 |
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