Cleared Traditional

K942284 - CLP TOTAL IRON AND UIBC/TIBC LINEARITY ...

K942284 is the FDA 510(k) clearance for CLP TOTAL IRON AND UIBC/TIBC LINEARITY ... by Creative Laboratory Products, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K942284 · Creative Laboratory Products, Inc. · Chemistry device
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Aug 1994
Decision
107d
Days
Class 1
Risk

K942284 is an FDA 510(k) clearance for the CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 107 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 K942284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1994
Decision Date August 26, 1994
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte 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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 372
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