510(k) K052485
K052485 is an FDA 510(k) premarket notification submitted by Midi, Inc. for the device "SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF". The FDA issued a decision of Substantially Equivalent on January 17, 2006. The device falls under product code NWZ (Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids), a Class II device regulated under 21 CFR 866.3045. Midi, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2006
- Date Received
- September 9, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
- Device Class
- Class II
- Regulation Number
- 866.3045
- Review Panel
- MI
- Submission Type
Aid in the identification of Bacillus Anthracis