Sigma Diagnostics, Inc. · Class II · Cleared Aug 10, 2000
| K-number | K001403 |
| Device name | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P |
| Applicant | Sigma Diagnostics, Inc. |
| Product code | CFR |
| Device class | Class II |
| Decision date | Aug 10, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
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