Cleared Traditional

DELTATEST (R) LIPASE II

K893718 · Electro-Nucleonics, Inc. · Chemistry
Sep 1989
Decision
134d
Days
Class 1
Risk

About This 510(k) Submission

K893718 is an FDA 510(k) clearance for the DELTATEST (R) LIPASE II, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 28, 1989, 134 days after receiving the submission on May 17, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K893718 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1989
Decision Date September 28, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CET — Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1465

Similar Devices — CET Olive Oil Emulsion (turbidimetric), Lipase

All 14
LIPASE REAGENT SET (COLIPASE METHOD)
K970124 · Teco Diagnostics · Mar 1997
LIPASE REAGENT SYSTEM
K940457 · Medical Diagnostic Technologies, Inc. · Jun 1994
LIPASE REAGENT SET
K915706 · Tech Intl. Co. · Feb 1992
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1990
LIPASE SR LIQUID STABLE REAGENT SET
K885078 · Medical Analysis Systems, Inc. · Mar 1989
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · Beckman Instruments, Inc. · Mar 1987