REDLINE ANTHRAX ALERT TEST— 510(k) K030370
Substantially EquivalentTetracore, Inc.
FDA 510(k) clearance K030370 for REDLINE ANTHRAX ALERT TEST, Substantially Equivalent on 2003-12-09. Applicant: Tetracore, Inc.. Device class: 2.
Clearance details
- Applicant
- Tetracore, Inc.
- Product code
- Code NPO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3045
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg,, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.