Cleared Traditional

LIPASE REAGENT SET

K790796 · Alta Diagnostics, Inc. · Chemistry
Jul 1979
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K790796 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 Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1979, 84 days after receiving the submission on April 24, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K790796 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1979
Decision Date July 17, 1979
Days to Decision 84 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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