510(k) K091409 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 6, 2010 |
| Received | May 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091409
No recall in the FDA data names this 510(k).
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