Alfa Wassermann Diagnostic Technologies, Inc. · Class II · Cleared Oct 2, 2013
| K-number | K131975 |
| Device name | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | CFJ |
| Device class | Class II |
| Decision date | Oct 2, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 862.1440 |
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