Cleared Traditional

SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933) - FDA 510(k) Clearance

Class I Chemistry device.

K973933 · Diagnostic Chemicals , Ltd. · Chemistry device
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Nov 1997
Decision
20d
Days
Class 1
Risk

K973933 is an FDA 510(k) clearance for the SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on November 4, 1997 after a review of 20 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. devices

Submission Details

510(k) Number K973933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date November 04, 1997
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric 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.

Regulatory Peers - JIY Photometric Method, Iron (non-heme)

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