Atlas FDA

JGY

22 FDA 510(k) clearances · Product code

48 daysmedian time to decision
134 days90th percentile
22clearances measured

FDA profile

Official device name
Colorimetric Method, Triglycerides
Device class
Class I (low risk)
Regulation
21 CFR 862.1705
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (K120664)Abaxis, Inc.2012-04-24
PICCOLO TRIGLYCERIDES TEST SYSTEM (K023639)Abaxis, Inc.2003-01-24
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K000586)Polymer Technology Systems, Inc.2000-07-03
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K991894)Polymer Technology Systems, Inc.2000-05-24
TRIGLYCERIDES (K971005)Derma Media Lab., Inc.1997-04-21
TRIGLYCERIDES REAGENT (K954187)Schiapparelli Biosystems, Inc.1995-10-23
DNA TRIGLYCERIDE PROCEDURE (K941063)Data Medical Associates, Inc.1994-07-20
IL TEST(TM) TRIGLYCERIDE (K931116)Instrumentation Laboratory CO1994-03-28
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (K914033)Cholestech Corp.1991-09-27
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (K905226)Enzyme Technology, Inc.1990-12-11
DMA TRIGLYCERIDE (GPO) PROCEDURE (K902202)Data Medical Associates, Inc.1990-07-31
TRIGLYCERIDE (GPO) TRINDER REAGENT (K894063)Sigma Diagnostics, Inc.1989-09-07
CLINISTAT TRIGLYCERIDES REAGENT TEST (K885134)Heraeus Kulzer, Inc.1989-02-10
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) (K860731)Trace Scientific , Ltd.1986-04-07
TRIGLYCERIDE REAGENT-TRINDER-GPO (K832460)Seppim, Inc.1983-09-12
TRIGLYZYME V EIKEN (K821106)Syn-Kit, Inc.1982-05-05
TRIGLYCERIDE REAGENT (COLOR) (K801012)Gilford Diagnostics1980-05-14
TRIGLYCERIDES TEST (500NM) (K800551)Reagents Applications, Inc.1980-03-25
ELVI TRIGLYCERIDE (K792414)Volu Sol Medical Industries1979-12-07
WORTHINGTON TRIGLYCERIDES REAGENT SET (K791962)Worthington Diagnostic Systems1979-11-05
TRIGLYCERIDE C-37 RAPID STAT KIT (K780825)Pierce Chemical Co.1978-05-26
TRI-CON TRIGLYCERIDGE REAGENTS (K761283)Dade, Baxter Travenol Diagnostics, Inc.1977-02-24

Track JGY automatically

Every clearance here is in the API, with alerts when new ones post.