Cleared Traditional

SEROTONIN ENZYME IMMUNOASSAY (K903609) - FDA 510(k) Clearance

Class I Chemistry device.

K903609 · Immunotech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
74d
Days
Class 1
Risk

K903609 is an FDA 510(k) clearance for the SEROTONIN ENZYME IMMUNOASSAY. Classified as Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin (product code CDA), Class I - General Controls.

Submitted by Immunotech Corp. (Cedex 9 (France), FR). The FDA issued a Cleared decision on October 22, 1990 after a review of 74 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.

View all Immunotech Corp. devices

Submission Details

510(k) Number K903609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1990
Decision Date October 22, 1990
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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.