Cleared Traditional

K832011 - AMERI CLEAR (FDA 510(k) Clearance)

Class I Hematology device.

K832011 · Stephens Scientific · Hematology device
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Aug 1983
Decision
50d
Days
Class 1
Risk

K832011 is an FDA 510(k) clearance for the AMERI CLEAR. Classified as Agent, Clearing (product code KEM), Class I - General Controls.

Submitted by Stephens Scientific (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.4010 - 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.

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Submission Details

510(k) Number K832011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date August 12, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEM Agent, Clearing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.