| K-number | K780311 |
| Device name | DIAGNOSTIC KIT, CPK |
| Applicant | Sclavo, Inc. |
| Product code | CGS |
| Device class | Class II |
| Decision date | Apr 5, 1978 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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