Cleared Traditional

K812594 - ULTRA ZYME PLUS AMYL #64982 & 65031
(FDA 510(k) Clearance)

K812594 · Harleco · Chemistry

Oct 1981

Decision

21d

Days

Class 2

Risk

K812594 is an FDA 510(k) clearance for the ULTRA ZYME PLUS AMYL #64982 & 65031. This device is classified as a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981, 21 days after receiving the submission on September 11, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number	K812594 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1981
Decision Date	October 02, 1981
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—