Cell-Free DNA BCT— 510(k) K231776

Substantially Equivalent

Streck, Inc.

FDA 510(k) clearance K231776 for Cell-Free DNA BCT, Substantially Equivalent on 2024-07-26. Applicant: Streck, Inc..

Clearance details

Applicant: Streck, Inc.
Product code: Code QMA
Advisory panel: Clinical Chemistry
Date received: 2023-06-16
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

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