Cleared Traditional

K904968 - QCLYTE PROTEIN BASED ISE CONTROL (FDA 510(k) Clearance)

K904968 · Baxter Healthcare Corp · Chemistry device

Dec 1990

Decision

31d

Days

Class 1

Risk

K904968 is an FDA 510(k) clearance for the QCLYTE PROTEIN BASED ISE CONTROL. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).

Submitted by Baxter Healthcare Corp (Danvers, US). The FDA issued a Cleared decision on December 6, 1990, 31 days after receiving the submission on November 5, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K904968 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1990
Decision Date	December 06, 1990
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 862.1660