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

Diazyme Laboratories — Predicate Candidate Screening

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

132 daysmedian FDA review time

273 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172992	Diazyme EZ Vitamin D Assay	Diazyme Laboratories	2018-01-11	106	0
K163418	Diazyme DZ-Lite Total beta-hCG Test System	Diazyme Laboratories	2017-08-18	255	0
K162297	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PC	Diazyme Laboratories	2017-04-18	245	0
K160762	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diaz	Diazyme Laboratories	2016-11-21	245	0
K153394	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La	Diazyme Laboratories	2016-11-18	360	0
K161646	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazym	Diazyme Laboratories	2016-11-04	142	0
K161721	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators S	Diazyme Laboratories	2016-09-20	90	0
K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set,	Diazyme Laboratories	2016-01-31	422	0
K133803	DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT	Diazyme Laboratories	2014-08-06	233	0
K133083	DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIA	Diazyme Laboratories	2014-06-24	267	0
K133410	DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTR	Diazyme Laboratories	2014-03-14	127	0
K131556	DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET	Diazyme Laboratories	2013-06-26	28	0
K123785	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	Diazyme Laboratories	2013-06-07	179	0
K112120	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET	Diazyme Laboratories	2013-01-24	549	0
K122420	DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITA	Diazyme Laboratories	2012-11-28	111	0
K121558	DIAZYME HSCRP POC TEST KIT	Diazyme Laboratories	2012-09-21	115	0
K121053	DIAZYME HOMOCYSTEINE POC TEST KIT	Diazyme Laboratories	2012-07-31	116	0
K111664	DIAZYME CYSTATIN C POC TEST KIT	Diazyme Laboratories	2012-03-30	290	0
K110188	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONT	Diazyme Laboratories	2011-05-17	113	0
K103557	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	Diazyme Laboratories	2011-04-27	146	0
K102432	DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME	Diazyme Laboratories	2011-01-14	141	0
K102638	DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS	Diazyme Laboratories	2010-11-30	77	0
K092911	SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY C	Diazyme Laboratories	2010-04-26	216	0
K093680	DIAZYME CYSTATIN C ASSAY	Diazyme Laboratories	2010-04-08	132	0
K091455	DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL D	Diazyme Laboratories	2009-08-14	88	0
K082001	DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B	Diazyme Laboratories	2008-12-05	144	0
K082763	DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B	Diazyme Laboratories	2008-11-12	51	0
K073488	DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR,	Diazyme Laboratories	2008-03-07	137	0
K072270	DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A	Diazyme Laboratories	2008-02-01	170	0
K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	Diazyme Laboratories	2008-01-03	129	0
K071971	DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALI	Diazyme Laboratories	2007-09-17	62	0
K062105	DIAZYME CREATININE LIQUID REAGENTS ASSAY	Diazyme Laboratories	2007-04-23	273	0
K070734	MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ	Diazyme Laboratories	2007-04-09	24	1
K060619	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A	Diazyme Laboratories	2006-07-21	135	0
K061296	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA A	Diazyme Laboratories	2006-06-13	35	0
K053566	MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ	Diazyme Laboratories	2006-02-15	55	0
K051714	TOTAL BILE ACIDS ASSAY, MODEL DZ042A	Diazyme Laboratories	2005-12-07	163	0
K042193	DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT	Diazyme Laboratories	2004-10-29	78	0
K042191	DIAZYME POTASSIUM ENZYMATIC ASSAY KIT	Diazyme Laboratories	2004-10-29	78	0
K042189	DIAZYME SODIUM ENZYMATIC ASSAY	Diazyme Laboratories	2004-10-07	56	0
K032012	HOMOCYSTEINE MICROTITER PLATE ASSAY	Diazyme Laboratories	2003-09-03	65	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