WOUNDCHEK Bacterial Status— 510(k) DEN180014

Unknown

Alere Scarborough, Inc.

FDA 510(k) clearance DEN180014 for WOUNDCHEK Bacterial Status, Unknown on 2019-12-02. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code QFA
Advisory panel: Microbiology
Date received: 2018-03-23
Decision date: 2019-12-02
Decision: Unknown
Clearance type: Direct
Location: Scarborough, ME, US

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