Cleared Traditional

K875176 - WAKO(TM) UIBC

K875176 is an FDA 510(k) clearance for WAKO(TM) UIBC, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code JQF cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K875176 · Wako Chemicals USA, Inc. · Chemistry device
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Feb 1988
Decision
47d
Days
Class 1
Risk

K875176 is an FDA 510(k) clearance for the WAKO(TM) UIBC. Classified as Bathophenanthroline, Iron Binding Capacity (product code JQF), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K875176

510(k) Number K875176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date February 02, 1988
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

JQF Device Classification - Class 1, General Controls

Product Code JQF Bathophenanthroline, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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 - JQF Bathophenanthroline, Iron Binding Capacity

Devices cleared under the same product code (JQF) and FDA review panel - the closest regulatory comparables to K875176.
SENTINEL UIBC LIQUID
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K984122 · Wako Chemicals USA, Inc. · Jan 1999
TRANSFERMETER
K863066 · J. D. Assoc. · Dec 1986
TOTAL IRON BINDING CAPACITY TEST
K830032 · Sclavo, Inc. · Jan 1983
IRON & TICB
K810086 · Bio-Analytics Laboratories, Inc. · Jan 1981
ELVI TOTAL IRON BINDING CAPACITY
K792409 · Volu Sol Medical Industries · Dec 1979