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

Verichem Laboratories, Inc. · Predicate Candidate Screening

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

77 daysmedian FDA review time

182 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112834	MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE	Verichem Laboratories, Inc.	2012-03-28	182	0
K974290	MICROPROTEIN STANDARD KIT	Verichem Laboratories, Inc.	1997-12-19	35	0
K973345	MATRIX PLUS MULTI-CALIBRATOR KIT	Verichem Laboratories, Inc.	1997-10-29	54	0
K972333	AMMONIA/IRON STANDARD KIT	Verichem Laboratories, Inc.	1997-07-23	30	5
K924904	HDL-CHOLESTEROL STANDARD, MODIFICATION	Verichem Laboratories, Inc.	1993-01-13	106	0
K912513	ELECTROLYTE CONTROL	Verichem Laboratories, Inc.	1991-07-19	43	0
K901113	MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD	Verichem Laboratories, Inc.	1990-03-29	22	0
K882059	BILIRUBIN STANDARD	Verichem Laboratories, Inc.	1988-10-25	162	0
K881320	URINE TOXICOLOGY STANDARD	Verichem Laboratories, Inc.	1988-09-09	165	0
K875285	MULTI-CHEMISTRY LINEARITY STANDARD	Verichem Laboratories, Inc.	1988-09-02	248	0
K882117	ETHYL ALCOHOL STANDARD	Verichem Laboratories, Inc.	1988-08-04	77	3
K882116	TOTAL PROTEIN/ALBUMIN STANDARD	Verichem Laboratories, Inc.	1988-06-24	36	0
K880705	THERAPEUTIC DRUG STANDARD	Verichem Laboratories, Inc.	1988-05-31	99	0
K880266	MULTI-ENZYME LINEARITY SOLUTION	Verichem Laboratories, Inc.	1988-02-18	27	0

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