Cleared Traditional

K823704 - ATS GRAM STAIN CONTROL SLIDE (FDA 510(k) Clearance)

Class I Hematology device.

K823704 · Alpha-Tec Systems, Inc. · Hematology device
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Jan 1983
Decision
29d
Days
Class 1
Risk

K823704 is an FDA 510(k) clearance for the ATS GRAM STAIN CONTROL SLIDE. Classified as Quality Control Slides (product code LJG), Class I - General Controls.

Submitted by Alpha-Tec Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.2660 - the FDA hematology 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 Alpha-Tec Systems, Inc. devices

Submission Details

510(k) Number K823704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1982
Decision Date January 07, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJG Quality Control Slides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.