510(k) K072631
K072631 is an FDA 510(k) premarket notification submitted by Idaho Technology, Inc. for the device "JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123". The FDA issued a decision of Substantially Equivalent on December 20, 2007. 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
- December 20, 2007
- Date Received
- September 18, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- 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.