Cleared Traditional

K833128 - FORMA-FAS-TEST

K833128 is an FDA 510(k) clearance for FORMA-FAS-TEST, manufactured by Chemical Detection & Experimentation. The device is a Class 2 Pathology device with product code LIF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

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.

FDA 510(k) Submission Details - K833128

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
210d slower than avg
Panel avg: 78d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LIF Dialyzer Reprocessing System

All 37
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K833128.
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · Seratronics, Inc. · Apr 1986
COBE REN NEW-D DISPENSING KIT
K853817 · Cobe Laboratories, Inc. · Oct 1985
RENATRON
K842258 · Renal Systems, Inc. · Jul 1984
HPR HOME PATIENT RENATRON
K833181 · Renal Systems, Inc. · Oct 1983
DIALYZER PREPARATION SYS DPS-4
K832230 · Seratronics, Inc. · Oct 1983
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
K833128 · FORMA-FAS-TEST
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