Cleared Traditional

K852948 - AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
(FDA 510(k) Clearance)

K852948 · Amresco, Inc. · Chemistry

Aug 1985

Decision

27d

Days

Class 2

Risk

K852948 is an FDA 510(k) clearance for the AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Amresco, Inc. (South Euclid, US). The FDA issued a Cleared decision on August 7, 1985, 27 days after receiving the submission on July 11, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number	K852948 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1985
Decision Date	August 07, 1985
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—