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

GGM — Predicate Candidate Screening

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

43 daysmedian FDA review time

126 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K192842	HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High	Eurotrol B.V.	2019-11-15	43
K182744	HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High	Eurotrol B.V.	2019-02-01	126
K070546	LYPHOCHEK DIABETES CONTROL	Bio-Rad Laboratories	2007-04-02	35
K070334	R&D SICKLE QC CONTROL	R&D Systems, Inc.	2007-03-29	52
K052838	LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4	Bio-Rad	2005-11-09	33
K032791	GLYCOHEMOSURE HBA1C CONTROL	Quantimetrix Corp.	2003-10-30	52
K003030	LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET	Bio-Rad	2000-11-29	62
K993321	R&D HGB/GLC WHOLE BLOOD CONTROL	R&D Systems, Inc.	1999-11-12	39
K964052	HEMOCUE HEMOTROL	Direct Solutions	1996-11-06	37
K963908	HEMOCUE HEMOLIN	Direct Solutions	1996-10-16	16
K921681	CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL	Isolab, Inc.	1992-11-17	223
K893985	HGB-CONTROL SET/MULTIPLE	R&D Systems, Inc.	1989-08-15	71
K852136	PRECINORM HB	Boehringer Mannheim Corp.	1985-07-05	50
K800296	WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3	Dade, Baxter Travenol Diagnostics, Inc.	1980-03-05	23
K790310	HEMOGLOBIN CONTROLS	Electrophoresis Corp.	1979-03-21	36

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