Cleared Special

K022767 - RAICHEM LIPID CALIBRATOR
(FDA 510(k) Clearance)

K022767 · Hemagen Diagnostics, Inc. · Chemistry

Sep 2002

Decision

13d

Days

Class 2

Risk

K022767 is an FDA 510(k) clearance for the RAICHEM LIPID CALIBRATOR. This device is classified as a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX).

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 3, 2002, 13 days after receiving the submission on August 21, 2002.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K022767 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2002
Decision Date	September 03, 2002
Days to Decision	13 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Statement