REDLINE ANTHRAX ALERT TEST
FDA 510(k) clearance K030370 · decided 2003-12-09
Clearance details
- K-number
- K030370
- Device name
- REDLINE ANTHRAX ALERT TEST
- Applicant
- Tetracore, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-04
- Decision date
- 2003-12-09
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- NPO
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Gaithersburg,, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.