MDx-Chex for BC-GP— 510(k) K231221

Substantially Equivalent

Streck

FDA 510(k) clearance K231221 for MDx-Chex for BC-GP, Substantially Equivalent on 2023-07-27. Applicant: Streck.

Clearance details

Applicant: Streck
Product code: Code PMN
Advisory panel: Microbiology
Date received: 2023-04-28
Decision date: 2023-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

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