LIPASE FLEX REAGENT CARTRIDGE— 510(k) K952816

Clearance details

Applicant

Dupont Medical Products

Product code

Code CHI

Device class

Class 1

Regulation

21 CFR 862.1465

Advisory panel

Clinical Chemistry

Date received

1995-06-20

Decision date

1995-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, DE, US

• K970905 — SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT1997-06-04
• K961179 — SENTINEL LIPASE LIQUID MODEL 17.401B1996-07-19
• K952180 — CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS1995-08-17
• K952647 — IL TEST LIPASE1995-07-20
• K941085 — LIPASE-PS ASSAY PROCEDURE NO. 8051994-05-17

• K952815 — DUPONT LIPASE CALIBRATOR1995-08-31
• K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD1995-08-11
• K952412 — DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL1995-06-23
• K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD1995-03-09
• K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE1994-12-28

• Z-0465-2019 — 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 plasma on the Dimension¿ clinical chemistry system.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180907
• Z-0466-2019 — 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 human serum and plasma on the Dimension Vista System.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180907

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952816.