Cleared Traditional

K823860 - NUCLIPASE (I125) PANCREATIC LIPASE

K823860 is an FDA 510(k) clearance for NUCLIPASE (I125) PANCREATIC LIPASE, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CET cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K823860 · Nuclear Diagnostics, Inc. · Chemistry device
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Apr 1983
Decision
117d
Days
Class 1
Risk

K823860 is an FDA 510(k) clearance for the NUCLIPASE (I125) PANCREATIC LIPASE. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1465 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuclear Diagnostics, Inc. devices

FDA 510(k) Submission Details - K823860

510(k) Number K823860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1982
Decision Date April 18, 1983
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

CET Device Classification - Class 1, General Controls

Product Code CET Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1465
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CET Olive Oil Emulsion (turbidimetric), Lipase

All 11
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