Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GGL — Predicate Candidate Screening

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

67 daysmedian FDA review time

426 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K083926	CD4 COUNT	Streck	2009-02-11	42
K051633	CD-CHEX PLUS BC	Streck	2005-08-16	57
K993126	CD-CHEX CD 34	Streck Laboratories, Inc.	1999-11-26	67
K960894	CD-CHEX + RBC	Streck Laboratories, Inc.	1996-05-24	80
K931825	CD-CHEX CD4 LOW	Streck Laboratories, Inc.	1994-06-06	426
K920997	CD-CHEX	Streck Laboratories, Inc.	1992-05-31	90
K894651	COULTER POSITIVE CONTROL CELLS	Coulter Corp.	1989-09-13	51
K891175	EDL ABNORMAL COAGULATION CONTROL	Elite Diagnostic , Ltd.	1989-04-10	35

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