Cleared Traditional

K862312 - ENZLIPASE, ENZYMATIC LIPASE KIT (FDA 510(k) Clearance)

Class I Chemistry device.

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

K862312 is an FDA 510(k) clearance for the ENZLIPASE, ENZYMATIC LIPASE KIT. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Northbrook, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 100 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

Submission Details

510(k) Number K862312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date September 26, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHI Lipase-esterase, Enzymatic, Photometric, 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.