Cleared Traditional

LIPASE REAGENT SET

K915706 · Tech Intl. Co. · Chemistry
Feb 1992
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K915706 is an FDA 510(k) clearance for the LIPASE REAGENT SET, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 18, 1992, 81 days after receiving the submission on November 29, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K915706 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1991
Decision Date February 18, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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