K231223

Substantially Equivalent

MDx-Chex for BC-GN

Applicant: Streck
Product 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.