Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Streck — Predicate Candidate Screening

33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time

296 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K254166	MDx-Chex for BCN	Streck	2026-03-23	90	0
K231221	MDx-Chex for BC-GP	Streck	2023-07-27	90	0
K231223	MDx-Chex for BC-GN	Streck	2023-07-27	90	0
K170091	UA-Cellular Complete	Streck	2017-02-09	30	0
K160585	XN CAL	Streck	2016-12-22	296	0
K160588	XN CHECK BF	Streck	2016-12-22	296	0
K160590	XN CHECK	Streck	2016-12-22	296	0
K160586	XN-L CHECK	Streck	2016-12-22	296	0
K141964	XN CHECK	Streck	2014-12-05	140	0
K141962	XN CAL	Streck	2014-12-05	140	0
K141955	XN CAL PF	Streck	2014-12-05	140	0
K141957	XN CHECK BF	Streck	2014-12-05	140	0
K131444	UA-CELLULAR COMPLETE	Streck	2014-01-29	254	0
K120747	XN CAL PF	Streck	2012-10-22	224	0
K120744	XN CHECK BF	Streck	2012-10-19	221	0
K120742	XN CHECK	Streck	2012-10-19	221	0
K120745	XN CAL	Streck	2012-10-19	221	0
K111211	CELL-DYN 22 PLUS CONTROL	Streck	2011-12-22	237	0
K111204	CELL-DYN 22 PLUS CALIBRATOR	Streck	2011-12-22	237	0
K110718	CELL-CHEX WITH CPPD CRYSTALS	Streck	2011-05-26	72	0
K101335	CELL-CHEX	Streck	2010-08-23	103	0
K090201	UA-CELLULAR FOR IQ	Streck	2009-03-27	59	0
K090137	STAK-CHEX PLUS RETICS	Streck	2009-03-18	56	0
K083926	CD4 COUNT	Streck	2009-02-11	42	0
K083200	X-CAL	Streck	2009-02-03	96	0
K080552	CYTO-CHEX BCT	Streck	2008-07-31	154	1
K080016	NRBC-CHEX FOR ADVIA	Streck	2008-02-05	33	0
K070199	RETIC-CHEX LINEARITY FOR BC	Streck	2007-02-23	32	0
K063218	E-CHECK (XE)	Streck	2006-12-14	51	0
K060083	NRBC-CHEX FOR LH	Streck	2006-02-09	29	0
K053362	CELL-CHEX AUTO	Streck	2006-01-13	42	0
K051706	IQ BODY FLUIDS CONTROL	Streck	2005-08-17	51	0
K051633	CD-CHEX PLUS BC	Streck	2005-08-16	57	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda