Cleared Traditional

LIPASE REAGENT SET (COLIPASE METHOD)

K970124 · Teco Diagnostics · Chemistry
Mar 1997
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K970124 is an FDA 510(k) clearance for the LIPASE REAGENT SET (COLIPASE METHOD), a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on March 6, 1997, 51 days after receiving the submission on January 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K970124 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 1997
Decision Date March 06, 1997
Days to Decision 51 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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