Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MHI — Predicate Candidate Screening

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

105 daysmedian FDA review time

262 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120001	UNIGOLD GIARDIA	Trinity Biotech	2013-03-01	423	0
K103673	GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK	Techlab Inc., Corporate Research Center	2011-08-18	245	0
K081064	GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-L	Ivd Research, Inc.	2009-01-14	275	0
K031942	XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020	Remel, Inc.	2003-11-18	147	0
K031834	XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY	Remel, Inc.	2003-11-10	150	1
K033274	GIARDIA II	Techlab, Inc.	2003-11-04	25	0
K024113	IVD CRYPTO/GIARDIA DFA	Ivd Research, Inc.	2003-03-05	82	0
K020583	IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96	Ivd Research, Inc.	2002-09-17	208	0
K983399	GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY	Genzyme Diagnostics	1999-01-11	105	2
K982711	PREMIER GIARDIA	Meridian Diagnostics, Inc.	1998-11-25	113	0
K982245	TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA	Biosite Incorporated	1998-10-06	102	0
K963135	GIARDIA CELISA	Techlab, Inc.	1996-11-29	109	0
K955897	CRYPTO/GIARDIA-CEL IF TEST	Techlab, Inc.	1996-08-05	223	0
K955157	PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY	Alexon Biomedical, Inc.	1996-02-09	88	2
K952467	TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)	Trend Scientific, Inc.	1995-11-20	178	0
K953284	TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM	Trend Scientific, Inc.	1995-10-06	85	0
K944871	LMD GIARDIA ANTIGEN DETECTION ASSAY	Lmd Laboratories	1995-06-22	262	0
K942098	PROSPECT GIARDIA	Alexon, Inc.	1994-09-09	148	0
K931147	PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION	Alexon, Inc.	1993-05-13	69	0
K930451	PROSPEC T GIARDIA MICROTITER ASSAY	Alexon, Inc.	1993-04-21	84	0
K922675	PROSPECT GIARDIA CONTROLS	Alexon, Inc.	1992-09-11	99	0
K922010	PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION	Alexon, Inc.	1992-06-19	50	0
K920817	MODIFICATION PROSPECT GIARDIA RAPID ASSAY	Alexon, Inc.	1992-04-22	76	0
K915093	PROSPECT(TM) GIARDIA RAPID ASSAY	Alexon, Inc.	1992-01-30	79	0
K911337	PROSPEC T/GIARDIA RAPID ASSAY	Alexon, Inc.	1991-09-27	185	0
K912152	CELLABS GIARDIA CEL I.F. TEST	Celltech Diagnostics , Ltd.	1991-08-12	89	0
K912408	MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA	Meridian Diagnostics, Inc.	1991-07-24	54	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