Cleared Traditional

K984119 - WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (FDA 510(k) Clearance)

Class I Chemistry device.

K984119 · Wako Chemicals USA, Inc. · Chemistry device
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Jan 1999
Decision
58d
Days
Class 1
Risk

K984119 is an FDA 510(k) clearance for the WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 15, 1999 after a review of 58 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K984119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date January 15, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFM Bathophenanthroline, Colorimetry, 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.