K-number	K231223
Device name	MDx-Chex for BC-GN
Applicant	Streck
Product code	PMN
Device class	Class II
Decision date	Jul 27, 2023
Decision	Substantially Equivalent
Regulation	866.3920

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Source

View the full FDA submission: accessdata.fda.gov

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MDx-Chex for BC-GN

Everything you need for a 510(k) submission. Nothing you don't.