CareStart Flu A&B Plus— 510(k) K191514

Substantially Equivalent

Access Bio, Inc.

FDA 510(k) clearance K191514 for CareStart Flu A&B Plus, Substantially Equivalent on 2020-02-18. Applicant: Access Bio, Inc.. Device class: 2.

Clearance details

Applicant: Access Bio, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2019-06-07
Decision date: 2020-02-18
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Access Bio, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.