Abbott Molecular, Inc. · Class II · Cleared Aug 9, 2011
| K-number | K100015 |
| Device name | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 |
| Applicant | Abbott Molecular, Inc. |
| Product code | OVQ |
| Device class | Class II |
| Decision date | Aug 9, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 866.6040 |
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