Cleared Traditional

LIPASE FLEX REAGENT CARTRIDGE

K952816 · Dupont Medical Products · Chemistry
Jul 1995
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K952816 is an FDA 510(k) clearance for the LIPASE FLEX REAGENT CARTRIDGE, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on July 20, 1995, 30 days after receiving the submission on June 20, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K952816 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1995
Decision Date July 20, 1995
Days to Decision 30 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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