510(k) K100015 ยท OVQ Chronic Lymphocytic Leukemia Fish Probe Kit
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Aug 9, 2011 |
| Received | Jan 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100015
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.