Cleared Traditional

SIMUL-FER SERUM IRON TEST KIT (K820253) - FDA 510(k) Clearance

Class I Chemistry device.

K820253 · Diagnostic Reagents, Inc. · Chemistry device
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May 1982
Decision
103d
Days
Class 1
Risk

K820253 is an FDA 510(k) clearance for the SIMUL-FER SERUM IRON TEST KIT. Classified as Radio-labeled Iron Method, Iron (non-heme) (product code JJA), Class I - General Controls.

Submitted by Diagnostic Reagents, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 12, 1982 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K820253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1982
Decision Date May 12, 1982
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJA Radio-labeled Iron Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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.