Cleared Traditional

K935176 - IRON TEST

K935176 is an FDA 510(k) clearance for IRON TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K935176 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1993
Decision
50d
Days
Class 1
Risk

K935176 is an FDA 510(k) clearance for the IRON TEST. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993 after a review of 50 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K935176

510(k) Number K935176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K935176.
ACE IRON REAGENT
K944911 · Schiapparelli Biosystems, Inc. · Feb 1995
IRON QVET
K943029 · Prisma Systems · Dec 1994
DMA IRON PROCEDURE
K944462 · Data Medical Associates, Inc. · Nov 1994
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · Em Diagnostic Systems, Inc. · Apr 1993
OLYMPUS IRON REAGENT
K924691 · Olympus Corp. · Dec 1992
OLYMPUS IRON REAGENT
K923565 · Olympus Corp. · Sep 1992