Alfa Wassermann · Class II · Cleared Jul 2, 2012
| K-number | K113435 |
| Device name | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
| Applicant | Alfa Wassermann |
| Product code | KHS |
| Device class | Class II |
| Decision date | Jul 2, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1160 |
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