Cleared Traditional

K844948 - SYVA SOLID PHASE COLUMNS

K844948 is an FDA 510(k) clearance for SYVA SOLID PHASE COLUMNS, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code KEA cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K844948 · Syva Co. · Chemistry device
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Aug 1985
Decision
252d
Days
Class 1
Risk

K844948 is an FDA 510(k) clearance for the SYVA SOLID PHASE COLUMNS. Classified as Resins, Ion-exchange (product code KEA), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K844948

510(k) Number K844948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date August 29, 1985
Days to Decision 252 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
163d slower than avg
Panel avg: 89d · This submission: 252d
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 K844948.
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997 · Atlantic Wholesale, Inc. · Mar 1989
CM-TRISACRYL M DEAE-TRISACRYL M
K842028 · Lkb Instruments, Inc. · Jun 1984
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
K844948 · SYVA SOLID PHASE COLUMNS
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