Cleared Traditional

K842155 - SERUM IRON & SERUM IRON BINDING CAPACI

K842155 is the FDA 510(k) clearance for SERUM IRON & SERUM IRON BINDING CAPACI by Diagnostic Chemicals, Ltd. (Usa). It is a Class 1 Chemistry device (product code CFM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K842155 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Aug 1984
Decision
69d
Days
Class 1
Risk

K842155 is an FDA 510(k) clearance for the SERUM IRON & SERUM IRON BINDING CAPACI. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K842155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date August 07, 1984
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFM Bathophenanthroline, Colorimetry, 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.

Regulatory Peers - CFM Bathophenanthroline, Colorimetry, Iron (non-heme)

All 17
Devices cleared under the same product code (CFM) and FDA review panel - the closest regulatory comparables to K842155.
TOTAL IRON BINDING CAPACITY PROCEDURE
K861602 · Data Medical Associates, Inc. · May 1986
DART IRON & IRON BINDING CAPACITY REAGENT
K854305 · Coulter Electronics, Inc. · Nov 1985
DATA CHEM IRON PROCEDURE
K852583 · Data Medical Associates, Inc. · Jul 1985
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
TDX REA IRON DIAGNOSTIC KIT
K842505 · Abbott Laboratories · Aug 1984
FEB TEST
K830564 · Wako Chemicals USA, Inc. · Mar 1983