Cleared Traditional

K812840 - SERUM IRON REAGENT SET

K812840 is an FDA 510(k) clearance for SERUM IRON REAGENT SET, manufactured by Anco Medical Reagents & Assoc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K812840 · Anco Medical Reagents & Assoc. · Chemistry device
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Dec 1981
Decision
55d
Days
Class 1
Risk

K812840 is an FDA 510(k) clearance for the SERUM IRON REAGENT SET. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 55 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 Anco Medical Reagents & Assoc. devices

FDA 510(k) Submission Details - K812840

510(k) Number K812840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1981
Decision Date December 03, 1981
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 K812840.
SERUM IRON & TIBC#65084 & 65085
K833017 · Emd Chemicals, Inc. · Nov 1983
SERUM IRON-PTF-600
K831201 · American Monitor Corp. · May 1983
SPIN CHEM REAGENTS & STANDARDS
K821184 · Smithkline Diagnostics, Inc. · May 1982
DIRECT IRON REAGENT SET
K812777 · The Dow Chemical Co. · Oct 1981
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · Diagnostic Solutions, Inc. · May 1980
TOTAL IRON IN SERUM
K782160 · Fisher Scientific Co., LLC · Jan 1979