Cleared Traditional

K851865 - AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
(FDA 510(k) Clearance)

K851865 · Amresco, Inc. · Chemistry

May 1985

Decision

21d

Days

Class 2

Risk

K851865 is an FDA 510(k) clearance for the AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Amresco, Inc. (South Euclid, US). The FDA issued a Cleared decision on May 20, 1985, 21 days after receiving the submission on April 29, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number	K851865 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 1985
Decision Date	May 20, 1985
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—