| K-number | K101335 |
| Device name | CELL-CHEX |
| Applicant | Streck |
| Product code | GLQ |
| Device class | Class II |
| Decision date | Aug 23, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 864.8625 |
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