NP Screen
FDA 510(k) clearance DEN190031 · decided 2020-05-11
Clearance details
- K-number
- DEN190031
- Device name
- NP Screen
- Applicant
- Advance Sentry Corporation
- Decision
- Unknown
- Date received
- 2019-06-24
- Decision date
- 2020-05-11
- Days to decision
- 322 days
- Clearance type
- Direct
- Product code
- OJY
- Device class
- 2
- Regulation number
- 866.3236
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Markham, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.