Cleared Traditional

LIPASE SR LIQUID STABLE REAGENT SET

K885078 · Medical Analysis Systems, Inc. · Chemistry
Mar 1989
Decision
95d
Days
Class 1
Risk

About This 510(k) Submission

K885078 is an FDA 510(k) clearance for the LIPASE SR LIQUID STABLE REAGENT SET, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on March 13, 1989, 95 days after receiving the submission on December 8, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K885078 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1988
Decision Date March 13, 1989
Days to Decision 95 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

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