WOUNDCHEK Bacterial Status— 510(k) DEN180014
UnknownAlere Scarborough, Inc.
FDA 510(k) clearance DEN180014 for WOUNDCHEK Bacterial Status, Unknown on 2019-12-02. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code QFA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3231
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Scarborough, ME, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.