510(k) K111394
K111394 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "MICROSCAN MICROSTEP". The FDA issued a decision of Substantially Equivalent on June 22, 2011. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2011
- Date Received
- May 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Panels, Test, Susceptibility, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type