Cleared Traditional

K890573 - KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT

K890573 is an FDA 510(k) clearance for KENLOR TOTAL IRON, manufactured by Kenlor Industries, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K890573 · Kenlor Industries, Inc. · Chemistry device
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Mar 1989
Decision
46d
Days
Class 1
Risk

K890573 is an FDA 510(k) clearance for the KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Kenlor Industries, Inc. (Westminster, US). The FDA issued a Cleared decision on March 24, 1989 after a review of 46 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 Kenlor Industries, Inc. devices

FDA 510(k) Submission Details - K890573

510(k) Number K890573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date March 24, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 62
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K890573.
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
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IRON SYSTEM PACK REAGENTS
K892838 · Boehringer Mannheim Corp. · Jun 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · Em Diagnostic Systems, Inc. · Jun 1989
BIOTROL IRON REAGENT
K890395 · Biotrol, USA, Inc. · Mar 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · Em Diagnostic Systems, Inc. · Feb 1989
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
K890034 · American Monitor Corp. · Feb 1989