Cleared Traditional

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY

K923917 · Nuclear Diagnostics, Inc. · Chemistry
Feb 1994
Decision
569d
Days
Class 1
Risk

About This 510(k) Submission

K923917 is an FDA 510(k) clearance for the ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY, 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 February 25, 1994, 569 days after receiving the submission on August 5, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K923917 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1992
Decision Date February 25, 1994
Days to Decision 569 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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