MILES LIPASE SERA-PAK METHOD— 510(k) K920337

Name: FDA 510(k) clearance K920337
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K920337 for MILES LIPASE SERA-PAK METHOD, Substantially Equivalent on 1992-03-11. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1992-01-24
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHI

view all

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
K952816 — LIPASE FLEX REAGENT CARTRIDGE1995-07-20

More clearances from Heraeus Kulzer, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.