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.

View all Syva Co. devices

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
164d slower than avg
Panel avg: 88d · 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.