Cleared Traditional

K964913 - IRON REAGENT

K964913 is an FDA 510(k) clearance for IRON REAGENT, manufactured by Derma Media Lab., Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K964913 · Derma Media Lab., Inc. · Chemistry device
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Feb 1997
Decision
73d
Days
Class 1
Risk

K964913 is an FDA 510(k) clearance for the IRON REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 73 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K964913

510(k) Number K964913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date February 20, 1997
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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 60
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K964913.
IRON
K981241 · Abbott Laboratories · May 1998
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · Diagnostic Chemicals , Ltd. · Nov 1997
IL TEST IRON
K972363 · Instrumentation Laboratory CO · Aug 1997
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · Pointe Scientific, Inc., · Nov 1996
ACE IRON REAGENT
K944911 · Schiapparelli Biosystems, Inc. · Feb 1995
IRON QVET
K943029 · Prisma Systems · Dec 1994