Product code CHI— Clinical Chemistry
ABBOTT A-GENT LIPASE REAGENT
- Classification name
- Lipase-Esterase, Enzymatic, Photometric, Lipase
- Device class
- Class 1
- Regulation
- 21 CFR 862.1465
- Advisory panel
- Clinical Chemistry
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code CHI
FDA has cleared devices under product code CHI between 1977 and 1997, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1996
- 1995
- 1994
- 1992
- 1990
- 1988
- 1987
- 1986
- 1985
- 1981
- 1980
- 1977
Top applicants under product code CHI
Recent clearances under product code CHI
- K970905 — SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
- K961179 — SENTINEL LIPASE LIQUID MODEL 17.401B
- K952180 — CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
- K952647 — IL TEST LIPASE
- K952816 — LIPASE FLEX REAGENT CARTRIDGE
- K941085 — LIPASE-PS ASSAY PROCEDURE NO. 805
- K923917 — ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
- K921249 — WAKO AUTOKIT LIPASE-COLOR
- K920337 — MILES LIPASE SERA-PAK METHOD
- K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125
- K897150 — LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
- K884596 — ABBOTT A-GENT LIPASE REAGENT
- K874027 — LIPASE UV [TOYO]
- K875173 — KODAK EKTACHEM DT SLIDES (LIPA)
- K874640 — WAKO(TM) AUTOKIT LIPASE
- K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT
- K845027 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
- K811553 — REAGENT SET TRIGLYCERIDES
- K802842 — SINGLE VIAL LIPASE TEST KIT
- K760786 — ENZYMATIC LIPASE MAX-PACK REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.