Hycor Biomedical, Inc. · Class II · Cleared Mar 5, 2008
| K-number | K080322 |
| Device name | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 |
| Applicant | Hycor Biomedical, Inc. |
| Product code | DHB |
| Device class | Class II |
| Decision date | Mar 5, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 866.5750 |
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