Cleared Traditional

K873372 - HVA & HOMOVANILLIC ACID BY HPLC METHOD (FDA 510(k) Clearance)

Class I Chemistry device.

K873372 · Bio-Rad · Chemistry device
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Dec 1987
Decision
120d
Days
Class 1
Risk

K873372 is an FDA 510(k) clearance for the HVA & HOMOVANILLIC ACID BY HPLC METHOD. Classified as Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin (product code CDF), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1795 - 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.

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Submission Details

510(k) Number K873372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date December 22, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDF Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1795
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.