Cleared Traditional

ENZLIPASE, ENZYMATIC LIPASE KIT

K862312 · Nuclear Diagnostics, Inc. · Chemistry
Sep 1986
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K862312 is an FDA 510(k) clearance for the ENZLIPASE, ENZYMATIC LIPASE KIT, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Nuclear Diagnostics, Inc. (Northbrook, US). The FDA issued a Cleared decision on September 26, 1986, 100 days after receiving the submission on June 18, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K862312 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1986
Decision Date September 26, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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