Cleared Traditional

K820253 - SIMUL-FER SERUM IRON TEST KIT

K820253 is an FDA 510(k) clearance for SIMUL-FER SERUM IRON TEST KIT, manufactured by Diagnostic Reagents, Inc.. The device is a Class 1 Chemistry device with product code JJA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K820253

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

JJA Device Classification - Class 1, General Controls

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.