Cleared Traditional

K952180 - CX LIPASE REAGENT & CALIBRATOR FOR SYNC...

K952180 is an FDA 510(k) clearance for CX LIPASE REAGENT & CALIBRATOR FOR SYNC..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CHI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K952180 · Beckman Instruments, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
100d
Days
Class 1
Risk

K952180 is an FDA 510(k) clearance for the CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 17, 1995 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K952180

510(k) Number K952180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date August 17, 1995
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

CHI Device Classification - Class 1, General Controls

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 12
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K952180.
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K920337 · Heraeus Kulzer, Inc. · Mar 1992