Cleared Traditional

K833128 - FORMA-FAS-TEST (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833128 · Chemical Detection & Experimentation · Pathology device
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Jun 1984
Decision
288d
Days
Class 2
Risk

K833128 is an FDA 510(k) clearance for the FORMA-FAS-TEST. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Chemical Detection & Experimentation (Walker, US). The FDA issued a Cleared decision on June 27, 1984 after a review of 288 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 876.5820 - the FDA pathology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K833128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1983
Decision Date June 27, 1984
Days to Decision 288 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 77d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.