Cleared Traditional

SENTINEL LIPASE LIQUID MODEL 17.401B (K961179) - FDA 510(k) Clearance

Class I Chemistry device.

K961179 · Equal Diagnostics, Inc. · Chemistry device
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Jul 1996
Decision
115d
Days
Class 1
Risk

K961179 is an FDA 510(k) clearance for the SENTINEL LIPASE LIQUID MODEL 17.401B. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Equal Diagnostics, Inc. (Exton, US). The FDA issued a Cleared decision on July 19, 1996 after a review of 115 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 Equal Diagnostics, Inc. devices

Submission Details

510(k) Number K961179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date July 19, 1996
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
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.

Regulatory Peers - CHI Lipase-esterase, Enzymatic, Photometric, Lipase

All 19
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K961179.
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IL TEST LIPASE
K952647 · Instrumentation Laboratory CO · Jul 1995
ABBOTT A-GENT LIPASE REAGENT
K884596 · Abbott Laboratories · Dec 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · Eastman Kodak Company · Feb 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · Eastman Kodak Company · Jan 1985