Applied Biosystems Bacillus anthracis Detection Kit
FDA 510(k) clearance K183462 · decided 2019-10-01
Clearance details
- K-number
- K183462
- Device name
- Applied Biosystems Bacillus anthracis Detection Kit
- Applicant
- Mriglobal
- Decision
- Substantially Equivalent
- Date received
- 2018-12-14
- Decision date
- 2019-10-01
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- QIF
- Advisory committee
- Immunology
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.