PYLORISCREEN
FDA 510(k) clearance K925190 · decided 1993-03-23
Clearance details
- K-number
- K925190
- Device name
- PYLORISCREEN
- Applicant
- New Horizons Diagnostics Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-14
- Decision date
- 1993-03-23
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.