Cleared Traditional

PARAMAX LIPASE REAGENT

K862440 · American Dade · Chemistry
Aug 1986
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K862440 is an FDA 510(k) clearance for the PARAMAX LIPASE REAGENT, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 4, 1986, 39 days after receiving the submission on June 26, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K862440 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1986
Decision Date August 04, 1986
Days to Decision 39 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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