Panels › Clinical Chemistry › Product code CHI · Class 1
Lipase-Esterase, Enzymatic, Photometric, Lipase
Regulation 862.1465
0510(k)s in 12 months (20 all time)
0recalls in 12 months (22 all time)
9recalls that name a 510(k)
Top companies in CHI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2023 | Ortho-Clinical Diagnostics, INc. VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge) Open, Classified |
CHI | None listed |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Jan 30, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Lipase, Ref. No. 01984894
B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the Terminated |
CHI | None listed |
| Feb 6, 2019 | Medica Corporation Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer
REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wa Terminated |
CHI | None listed |
| Oct 30, 2018 | Horiba Instruments Incorporated Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 Terminated |
CHI | None listed |
| Sep 7, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745
Product Usage:
Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in huma Terminated |
CHI | K952816 |
| Sep 7, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Lipase Flex Reagent Cartridge, Model Number 10460277
Product Usage:
Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and Terminated |
CHI | K952816 |
| Dec 14, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) Terminated |
CHI | None listed |
| Nov 21, 2017 | Medica Corporation Wash Kit (REF 10680) Lots 16279, 17045 and 17215
Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution i Terminated |
CHI | None listed |
| Apr 20, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. Terminated |
CHI | None listed |
| Oct 28, 2014 | Abbott Laboratories, Inc Lipase Reagent, 7D80.
Used to measure lipase in human serum on the Architect system. Terminated |
CHI | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749
VITROS LIPA Slides quantitatively measure Lipase (LIPA) a Terminated |
CHI | None listed |
| Dec 10, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension LIP Flex Reagent Cartridge, Catalog# DF55A Terminated |
CHI | K952816 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-E
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-D
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-C
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . Terminated |
CHI | K897150 |
| Aug 22, 2008 | Genzyme Corporation Equal Diagnostics Lipase Color Reagent Kit
Part Number: 905-B
For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01. Terminated |
CHI | K897150 |
| Sep 18, 2007 | Abbott Laboratories Inc. Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30 Terminated |
CHI | None listed |
| Dec 5, 2006 | Ortho-Clinical Diagnostics VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides p Terminated |
CHI | K845027 |
| Nov 30, 2004 | Beckman Coulter Inc SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 Terminated |
CHI | K970905 |
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