MDx-Chex for BC-GN— 510(k) K231223

Substantially Equivalent

Streck

FDA 510(k) clearance K231223 for MDx-Chex for BC-GN, Substantially Equivalent on 2023-07-27. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2023-04-28
Decision date: 2023-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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More clearances from Streck

K231221 — MDx-Chex for BC-GP2023-07-27
K170091 — UA-Cellular Complete2017-02-09
K160585 — XN CAL2016-12-22
K160586 — XN-L CHECK2016-12-22
K160588 — XN CHECK BF2016-12-22

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