MDx-Chex for BCN— 510(k) K254166

Substantially Equivalent

Streck

FDA 510(k) clearance K254166 for MDx-Chex for BCN, Substantially Equivalent on 2026-03-23. Applicant: Streck.

Clearance details

Applicant: Streck
Product code: Code PMN
Advisory panel: Microbiology
Date received: 2025-12-23
Decision date: 2026-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

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