PREMIER COCCIDIOIDES
FDA 510(k) clearance K915493 · decided 1992-07-10
Clearance details
- K-number
- K915493
- Device name
- PREMIER COCCIDIOIDES
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-09
- Decision date
- 1992-07-10
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- MIY
- Device class
- 2
- Regulation number
- 866.3135
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.