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

GLQ — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

56 daysmedian FDA review time

237 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K111211	CELL-DYN 22 PLUS CONTROL	Streck	2011-12-22	237
K110718	CELL-CHEX WITH CPPD CRYSTALS	Streck	2011-05-26	72
K101335	CELL-CHEX	Streck	2010-08-23	103
K090137	STAK-CHEX PLUS RETICS	Streck	2009-03-18	56
K000945	PARA 12 PLUS RETICS	Streck Laboratories, Inc.	2000-04-18	26
K994388	XE CHECK	Streck Laboratories, Inc.	2000-01-14	17
K992887	STAK-CHEX PLUS RETICS	Streck Laboratories, Inc.	1999-11-22	87
K823794	CONTROL TM 8	General Diagnostics	1983-01-14	29
K823587	UNI-CELL	Medical Specialties Laboratories	1983-01-05	30
K823498	PARA 12	Streck Laboratories, Inc.	1982-12-28	34

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