510(k) K113433
K113433 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT". The FDA issued a decision of Substantially Equivalent on April 4, 2012. The device falls under product code OMN (C. Difficile Nucleic Acid Amplification Test Assay), a Class I device regulated under 21 CFR 866.2660. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2012
- Date Received
- November 21, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- C. Difficile Nucleic Acid Amplification Test Assay
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.