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

Chem-Elec, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time

734 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K943503	CHEMCARD GLUCOSE TEST	Chem-Elec, Inc.	1996-07-23	734
K864159	SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD	Chem-Elec, Inc.	1988-06-10	596
K811406	CREATININE RATE REAGENT KIT	Chem-Elec, Inc.	1981-08-13	86
K811381	ASTRA	Chem-Elec, Inc.	1981-08-13	90
K811319	CHLORIDE REAGENT KIT	Chem-Elec, Inc.	1981-08-13	93
K811165	GLUCOSE OXIDASE RATE REAGENT	Chem-Elec, Inc.	1981-08-13	107
K811310	SODIUM/POTASSIUM REAGENT KITS	Chem-Elec, Inc.	1981-07-10	60
K811193	BUN RATE REAGENT	Chem-Elec, Inc.	1981-07-10	71
K811701	CHLORIDE/CARBON DIOXIDE RATE REAGENT	Chem-Elec, Inc.	1981-07-01	15

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