Cleared Traditional

PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX

K901141 · Baxter Healthcare Corp · Chemistry

Apr 1990

Decision

27d

Days

Class 1

Risk

About This 510(k) Submission

K901141 is an FDA 510(k) clearance for the PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 9, 1990, 27 days after receiving the submission on March 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K901141 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1990
Decision Date	April 09, 1990
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JJC — Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2150