Cleared Traditional

AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030

K881056 · American Research Products Co. · Chemistry

Nov 1988

Decision

249d

Days

Class 1

Risk

About This 510(k) Submission

K881056 is an FDA 510(k) clearance for the AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on November 15, 1988, 249 days after receiving the submission on March 11, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K881056 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1988
Decision Date	November 15, 1988
Days to Decision	249 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