Cleared Traditional

K896465 - CLP CK/LD ISOENZYME/IMMUNO CONTROL

K896465 is an FDA 510(k) clearance for CLP CK/LD ISOENZYME/IMMUNO CONTROL, manufactured by Creative Laboratory Products, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K896465

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

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 80
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K896465.
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