Cleared Traditional

K873366 - WAKO(TM) PRETEST 5A

K873366 is an FDA 510(k) clearance for WAKO(TM) PRETEST 5A, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code CDM cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K873366 · Wako Chemicals USA, Inc. · Chemistry device
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Jan 1988
Decision
153d
Days
Class 1
Risk

K873366 is an FDA 510(k) clearance for the WAKO(TM) PRETEST 5A. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on January 21, 1988 after a review of 153 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1785 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K873366

510(k) Number K873366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date January 21, 1988
Days to Decision 153 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
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

CDM Device Classification - Class 1, General Controls

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
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.