510(k) K033415 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
IDI-MRSA
| Applicant | Infectio Diagnostic (I.D.I.), Inc., Sainte-Foy, CA |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Oct 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2005 | Cepheid SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler Terminated |
NSR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.