Cleared Traditional

CLP CK/LD ISOENZYME/IMMUNO CONTROL (K896465) - FDA 510(k) Clearance

Class I Chemistry device.

K896465 · Creative Laboratory Products, Inc. · Chemistry device
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Mar 1990
Decision
108d
Days
Class 1
Risk

K896465 is an FDA 510(k) clearance for the CLP CK/LD ISOENZYME/IMMUNO CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Creative Laboratory Products, Inc. devices

Submission Details

510(k) Number K896465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date March 01, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 96
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