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

JGY — Predicate Candidate Screening

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

48 daysmedian FDA review time

134 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K120664	PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM	Abaxis, Inc.	2012-04-24	50
K023639	PICCOLO TRIGLYCERIDES TEST SYSTEM	Abaxis, Inc.	2003-01-24	86
K000586	BIOSCANNER TRIGLYCERIDES TEST STRIPS	Polymer Technology Systems, Inc.	2000-07-03	132
K991894	BIOSCANNER TRIGLYCERIDES TEST STRIPS	Polymer Technology Systems, Inc.	2000-05-24	356
K971005	TRIGLYCERIDES	Derma Media Lab., Inc.	1997-04-21	33
K954187	TRIGLYCERIDES REAGENT	Schiapparelli Biosystems, Inc.	1995-10-23	47
K941063	DNA TRIGLYCERIDE PROCEDURE	Data Medical Associates, Inc.	1994-07-20	134
K931116	IL TEST(TM) TRIGLYCERIDE	Instrumentation Laboratory CO	1994-03-28	389
K914033	CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST	Cholestech Corp.	1991-09-27	17
K905226	TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL	Enzyme Technology, Inc.	1990-12-11	21
K902202	DMA TRIGLYCERIDE (GPO) PROCEDURE	Data Medical Associates, Inc.	1990-07-31	76
K894063	TRIGLYCERIDE (GPO) TRINDER REAGENT	Sigma Diagnostics, Inc.	1989-09-07	91
K885134	CLINISTAT TRIGLYCERIDES REAGENT TEST	Heraeus Kulzer, Inc.	1989-02-10	60
K860731	TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)	Trace Scientific , Ltd.	1986-04-07	40
K832460	TRIGLYCERIDE REAGENT-TRINDER-GPO	Seppim, Inc.	1983-09-12	48
K821106	TRIGLYZYME V EIKEN	Syn-Kit, Inc.	1982-05-05	15
K801012	TRIGLYCERIDE REAGENT (COLOR)	Gilford Diagnostics	1980-05-14	16
K800551	TRIGLYCERIDES TEST (500NM)	Reagents Applications, Inc.	1980-03-25	15
K792414	ELVI TRIGLYCERIDE	Volu Sol Medical Industries	1979-12-07	11
K791962	WORTHINGTON TRIGLYCERIDES REAGENT SET	Worthington Diagnostic Systems	1979-11-05	35
K780825	TRIGLYCERIDE C-37 RAPID STAT KIT	Pierce Chemical Co.	1978-05-26	7
K761283	TRI-CON TRIGLYCERIDGE REAGENTS	Dade, Baxter Travenol Diagnostics, Inc.	1977-02-24	66

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