Cleared Traditional

K844948 - SYVA SOLID PHASE COLUMNS (FDA 510(k) Clearance)

Aug 1985
Decision
252d
Days
Class 1
Risk

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

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 29, 1985, 252 days after receiving the submission on December 20, 1984.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2230.

Submission Details

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

Device Classification

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