Cleared Traditional

K842028 - CM-TRISACRYL M DEAE-TRISACRYL M

K842028 is an FDA 510(k) clearance for CM-TRISACRYL M DEAE-TRISACRYL M, manufactured by Lkb Instruments, Inc.. The device is a Class 1 Chemistry device with product code KEA cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K842028 · Lkb Instruments, Inc. · Chemistry device
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Jun 1984
Decision
20d
Days
Class 1
Risk

K842028 is an FDA 510(k) clearance for the CM-TRISACRYL M DEAE-TRISACRYL M. Classified as Resins, Ion-exchange (product code KEA), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2230 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K842028

510(k) Number K842028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1984
Decision Date June 07, 1984
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

KEA Device Classification - Class 1, General Controls

Product Code KEA Resins, Ion-exchange
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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.

Regulatory Peers - KEA Resins, Ion-exchange

All 8
Devices cleared under the same product code (KEA) and FDA review panel - the closest regulatory comparables to K842028.
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997 · Atlantic Wholesale, Inc. · Mar 1989
SYVA SOLID PHASE COLUMNS
K844948 · Syva Co. · Aug 1985
AMBERLITE CG50 RESIN, 100-200 MESH
K833320 · Biosan Laboratories, Inc. · Dec 1983
BIO-REX 70 RESIN 100-200 MESH PH6.2
K833319 · Biosan Laboratories, Inc. · Nov 1983
EXTRELUT QE EXTRACTION COLUMNS
K831027 · Emd Chemicals, Inc. · May 1983
I.E.C COLUMN
K830918 · Berwick Medical Products, Inc. · Apr 1983
K842028 · CM-TRISACRYL M DEAE-TRISACRYL M
Download PDF Lkb Instruments, Inc.