MDx-Chex for BCID2— 510(k) K212576

Substantially Equivalent

Streck, Inc.

FDA 510(k) clearance K212576 for MDx-Chex for BCID2, Substantially Equivalent on 2022-01-19. Applicant: Streck, Inc.. Device class: 2.

Clearance details

Applicant: Streck, Inc.
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2021-08-16
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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