Cleared Traditional

K812595 - ULTRA CHEM E-GLU #64976 & 65040
(FDA 510(k) Clearance)

K812595 · Harleco · Chemistry

Sep 1981

Decision

18d

Days

Class 2

Risk

K812595 is an FDA 510(k) clearance for the ULTRA CHEM E-GLU #64976 & 65040. This device is classified as a Hexokinase, Glucose (Class II — Special Controls, product code CFR).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981, 18 days after receiving the submission on September 11, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K812595 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1981
Decision Date	September 29, 1981
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—