Streck, LLC

Code	Device name	Class	Specialty	Clearances	Most recent
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Class II	Microbiology	6	2026-03-27
QMA	Blood Collection Device For Cell-Free Nucleic Acid	Class II	Clinical Chemistry	2	2024-07-26

Date	K-number	Device	Code	Class	Specialty
2026-03-27	K260041	MDx-Chex for BCP	PMN	Class II	Microbiology
2026-03-23	K254166	MDx-Chex for BCN	PMN	Class II	Microbiology
2026-03-17	K254167	MDx-Chex for BCY	PMN	Class II	Microbiology
2024-07-26	K231776	Cell-Free DNA BCT	QMA	Class II	Clinical Chemistry
2023-07-27	K231223	MDx-Chex for BC-GN	PMN	Class II	Microbiology
2023-07-27	K231221	MDx-Chex for BC-GP	PMN	Class II	Microbiology
2022-01-19	K212576	MDx-Chex for BCID2	PMN	Class II	Microbiology
2020-08-07	DEN200001	Cell-Free DNA BCT	QMA	Class II	Clinical Chemistry

Clearance cadence by quarter