510(k) K051713
K051713 is an FDA 510(k) premarket notification submitted by Idaho Technology, Inc. for the device "JBAIDS ANTHRAC DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 2005. The device falls under product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis), a Class II device regulated under 21 CFR 866.3045. Idaho Technology, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2005
- Date Received
- June 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device Class
- Class II
- Regulation Number
- 866.3045
- Review Panel
- MI
- Submission Type
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.