Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Pierce Chemical Co. · Predicate Candidate Screening

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

37 daysmedian FDA review time

78 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K895661	GLYCOTEST II GLYHB ASSAY KIT	Pierce Chemical Co.	1989-12-07	78
K831837	CLINOVATIVE II DIAGNOSTIC KIT	Pierce Chemical Co.	1983-08-01	55
K821360	GLYCO-GEL TEST KIT	Pierce Chemical Co.	1982-06-02	26
K820279	GLYCO-GEL TEST KIT	Pierce Chemical Co.	1982-04-08	65
K781897	STAT KIT, MICROPROTEIN	Pierce Chemical Co.	1979-01-10	58
K780827	URIC ACID RAPID STAT KIT	Pierce Chemical Co.	1978-06-13	25
K780825	TRIGLYCERIDE C-37 RAPID STAT KIT	Pierce Chemical Co.	1978-05-26	7
K780826	BILIRUBIN RAPID STAT KIT	Pierce Chemical Co.	1978-05-26	7
K780512	AUTO/STAT KIT	Pierce Chemical Co.	1978-05-03	34
K780331	CHOLESTEROL RAPID SLAT KIT HDL	Pierce Chemical Co.	1978-04-06	37

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