Cleared Traditional

K952817 - BIO-RAD URINARY 5-HIAA BY HPLC (FDA 510(k) Clearance)

Class I Chemistry device.

K952817 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
42d
Days
Class 1
Risk

K952817 is an FDA 510(k) clearance for the BIO-RAD URINARY 5-HIAA BY HPLC. Classified as Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin (product code CDA), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on August 1, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1390 - 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.

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Submission Details

510(k) Number K952817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1995
Decision Date August 01, 1995
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDA Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1390
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.