WOUNDCHEK Bacterial Status
FDA 510(k) clearance DEN180014 · decided 2019-12-02
Clearance details
- K-number
- DEN180014
- Device name
- WOUNDCHEK Bacterial Status
- Applicant
- Alere Scarborough, Inc.
- Decision
- Unknown
- Date received
- 2018-03-23
- Decision date
- 2019-12-02
- Days to decision
- 619 days
- Clearance type
- Direct
- Product code
- QFA
- Device class
- 2
- Regulation number
- 866.3231
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.