Atlas FDA

CHI

20 FDA 510(k) clearances · Product code

70 daysmedian time to decision
238 days90th percentile
20clearances measured

FDA profile

Official device name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class
Class I (low risk)
Regulation
21 CFR 862.1465
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2011: 4 · 2020: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905)Beckman Instruments, Inc.1997-06-04
SENTINEL LIPASE LIQUID MODEL 17.401B (K961179)Equal Diagnostics, Inc.1996-07-19
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180)Beckman Instruments, Inc.1995-08-17
IL TEST LIPASE (K952647)Instrumentation Laboratory CO1995-07-20
LIPASE FLEX REAGENT CARTRIDGE (K952816)Dupont Medical Products1995-07-20
LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085)Sigma Diagnostics, Inc.1994-05-17
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (K923917)Nuclear Diagnostics, Inc.1994-02-25
WAKO AUTOKIT LIPASE-COLOR (K921249)Wako Chemicals USA, Inc.1992-07-21
MILES LIPASE SERA-PAK METHOD (K920337)Heraeus Kulzer, Inc.1992-03-11
COLORIMETRIC CHLORIDE PRODUCT #4314125 (K900827)American Research Products Co.1990-05-02
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150)Toyo Jozo Co., Ltd.1990-02-26
ABBOTT A-GENT LIPASE REAGENT (K884596)Abbott Laboratories1988-12-06
LIPASE UV [TOYO] (K874027)Advocacy International, Ltd.1988-05-27
KODAK EKTACHEM DT SLIDES (LIPA) (K875173)Eastman Kodak Company1988-02-24
WAKO(TM) AUTOKIT LIPASE (K874640)Wako Chemicals USA, Inc.1987-12-22
ENZLIPASE, ENZYMATIC LIPASE KIT (K862312)Nuclear Diagnostics, Inc.1986-09-26
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K845027)Eastman Kodak Company1985-01-18
REAGENT SET TRIGLYCERIDES (K811553)Boehringer Mannheim Corp.1981-06-18
SINGLE VIAL LIPASE TEST KIT (K802842)Biodynamics Corp.1980-12-18
ENZYMATIC LIPASE MAX-PACK REAGENT (K760786)Calbiochem1977-01-06

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