510(k) K030370
K030370 is an FDA 510(k) premarket notification submitted by Tetracore, Inc. for the device "REDLINE ANTHRAX ALERT TEST". The FDA issued a decision of Substantially Equivalent on December 9, 2003. The device falls under product code NPO (Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody), a Class II device regulated under 21 CFR 866.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2003
- Date Received
- February 4, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
- Device Class
- Class II
- Regulation Number
- 866.3045
- Review Panel
- MI
- Submission Type
A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth