Cleared Traditional

K813043 - ULTRACHEM CREA ITEM #64972
(FDA 510(k) Clearance)

K813043 · Harleco · Chemistry

Nov 1981

Decision

13d

Days

Class 2

Risk

K813043 is an FDA 510(k) clearance for the ULTRACHEM CREA ITEM #64972. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 10, 1981, 13 days after receiving the submission on October 28, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K813043 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1981
Decision Date	November 10, 1981
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—