Cleared Traditional

K782160 - TOTAL IRON IN SERUM

K782160 is an FDA 510(k) clearance for TOTAL IRON IN SERUM, manufactured by Fisher Scientific Co., LLC. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K782160 · Fisher Scientific Co., LLC · Chemistry device
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Jan 1979
Decision
36d
Days
Class 1
Risk

K782160 is an FDA 510(k) clearance for the TOTAL IRON IN SERUM. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 36 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K782160

510(k) Number K782160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1978
Decision Date January 26, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

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)

All 61
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K782160.
SERUM IRON REAGENT SET
K812840 · Anco Medical Reagents & Assoc. · Dec 1981
DIRECT IRON REAGENT SET
K812777 · The Dow Chemical Co. · Oct 1981
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · Diagnostic Solutions, Inc. · May 1980
IRON BINDING CAPICITY MODEL 0370
K781865 · Stanbio Laboratory · Dec 1978
SERUM IRON
K771838 · Gamma Enterprises, Inc. · Nov 1977