Cleared Traditional

IL TEST LIPASE

K952647 · Instrumentation Laboratory CO · Chemistry
Jul 1995
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K952647 is an FDA 510(k) clearance for the IL TEST LIPASE, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on July 20, 1995, 41 days after receiving the submission on June 9, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K952647 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1995
Decision Date July 20, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHI — Lipase-esterase, Enzymatic, Photometric, Lipase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1465

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