Cleared Traditional

EMIT D.A.U. LOW & MEDIUM CALIBRATOR A (K894327) - FDA 510(k) Clearance

Class I Toxicology device.

K894327 · Syva Co. · Toxicology device
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Aug 1989
Decision
20d
Days
Class 1
Risk

K894327 is an FDA 510(k) clearance for the EMIT D.A.U. LOW & MEDIUM CALIBRATOR A. Classified as Plate, Cellulose, Tlc (product code DKG), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2270 - 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 Syva Co. devices

Submission Details

510(k) Number K894327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date August 03, 1989
Days to Decision 20 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
67d faster than avg
Panel avg: 87d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DKG Plate, Cellulose, Tlc
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2270
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.