Alfa Wassermann Diagnostic Technologies, Inc. · Class I · Cleared Jun 1, 2012
| K-number | K113438 |
| Device name | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | JMO |
| Device class | Class I |
| Decision date | Jun 1, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1415 |
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