Cleared Traditional

TENONE(TM) OPIATES CATALOG: VKSO1,4 (K902055) - FDA 510(k) Clearance

Class I Toxicology device.

K902055 · Diagnostic Products Corp. · Toxicology device
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Jul 1990
Decision
64d
Days
Class 1
Risk

K902055 is an FDA 510(k) clearance for the TENONE(TM) OPIATES CATALOG: VKSO1,4. Classified as Carbonic Anhydrase C, Antigen, Antiserum, Control (product code DDE), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 10, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.5200 - the FDA toxicology device 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K902055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date July 10, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDE Carbonic Anhydrase C, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5200
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.