QUICKELISA ANTHRAX-PA KIT
FDA 510(k) clearance K040407 · decided 2004-06-03
Clearance details
- K-number
- K040407
- Device name
- QUICKELISA ANTHRAX-PA KIT
- Applicant
- Immunetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-17
- Decision date
- 2004-06-03
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- NRL
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.