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

Lin-Zhi International, Inc. · Predicate Candidate Screening

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

81 daysmedian FDA review time

337 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253082	LZI Buprenorphine II Enzyme Immunoassay	Lin-Zhi International, Inc.	2026-01-16	115	0
K251634	LZI Fentanyl III Enzyme Immunoassay	Lin-Zhi International, Inc.	2025-06-18	20	0
K202007	LZI Oxycodone III Enzyme Immunoassay	Lin-Zhi International, Inc.	2020-09-17	58	0
K201938	LZI Fentanyl II Enzyme Immunoassay	Lin-Zhi International, Inc.	2020-08-07	25	0
K201223	LZI Tramadol Enzyme Immunoassay	Lin-Zhi International, Inc.	2020-06-04	29	0
K192299	LZI Cotinine II Enzyme Immunoassay	Lin-Zhi International, Inc.	2019-11-21	90	0
K192433	LZI Methadone II Enzyme Immunoassay	Lin-Zhi International, Inc.	2019-10-04	29	0
K181159	LZI Fentanyl Enzyme Immunoassay	Lin-Zhi International, Inc.	2018-12-03	216	0
DEN170010	LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay	Lin-Zhi International, Inc.	2018-04-20	423	0
K170416	LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone M	Lin-Zhi International, Inc.	2017-06-26	136	0
K141320	LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Flu	Lin-Zhi International, Inc.	2015-05-28	373	0
K141205	LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL	Lin-Zhi International, Inc.	2015-02-13	280	0
K141055	LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15	Lin-Zhi International, Inc.	2014-06-13	50	0
K131652	LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATO	Lin-Zhi International, Inc.	2014-03-21	289	0
K133710	LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS	Lin-Zhi International, Inc.	2014-02-21	79	0
K131653	LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS,	Lin-Zhi International, Inc.	2014-02-04	244	0
K120763	LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE	Lin-Zhi International, Inc.	2012-06-01	80	0
K120761	LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2	Lin-Zhi International, Inc.	2012-05-08	56	0
K113661	LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE C	Lin-Zhi International, Inc.	2012-01-23	41	0
K113139	LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBR	Lin-Zhi International, Inc.	2011-11-22	29	0
K110298	OPIATE ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2011-07-15	164	0
K110239	LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALI	Lin-Zhi International, Inc.	2011-06-23	148	0
K102210	LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPH	Lin-Zhi International, Inc.	2010-12-28	145	0
K101195	6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CA	Lin-Zhi International, Inc.	2010-07-06	68	0
K090844	BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIB	Lin-Zhi International, Inc.	2009-07-30	125	0
K081008	BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS F	Lin-Zhi International, Inc.	2008-12-22	256	2
K063024	LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUN	Lin-Zhi International, Inc.	2006-10-30	28	0
K062242	METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; C	Lin-Zhi International, Inc.	2006-09-29	58	0
K050988	OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATOR	Lin-Zhi International, Inc.	2006-04-06	352	0
K050945	ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2006-03-29	349	0
K051058	METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRA	Lin-Zhi International, Inc.	2006-03-29	337	0
K051088	MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTRO	Lin-Zhi International, Inc.	2005-06-24	57	3
K050733	OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND C	Lin-Zhi International, Inc.	2005-06-13	88	0
K033885	BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT	Lin-Zhi International, Inc.	2004-05-19	156	0
K033866	CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (	Lin-Zhi International, Inc.	2004-04-07	117	0
K033094	ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), C	Lin-Zhi International, Inc.	2003-12-19	81	0
K032764	BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT);	Lin-Zhi International, Inc.	2003-11-03	59	1
K031797	METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190	Lin-Zhi International, Inc.	2003-10-10	122	0
K032461	ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221	Lin-Zhi International, Inc.	2003-10-03	53	0
K032365	BENZODIAZEPINE ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2003-09-05	36	0
K023795	PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT	Lin-Zhi International, Inc.	2003-01-21	69	0
K023316	SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Lin-Zhi International, Inc.	2002-12-16	74	0
K023317	METHADONE ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2002-12-12	70	0
K021887	CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071	Lin-Zhi International, Inc.	2002-08-15	69	0
K021449	CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Lin-Zhi International, Inc.	2002-06-18	43	1
K020368	OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); C	Lin-Zhi International, Inc.	2002-06-04	120	0
K020395	AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KI	Lin-Zhi International, Inc.	2002-06-04	118	0
K020254	PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 001	Lin-Zhi International, Inc.	2002-05-10	106	0
K020763	COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TEST	Lin-Zhi International, Inc.	2002-05-10	64	0
K020769	SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Lin-Zhi International, Inc.	2002-04-03	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