Cleared Abbreviated

Multichem A1c

K162514 · Technopath Manufacturing · Chemistry

Oct 2016

Decision

48d

Days

Class 1

Risk

About This 510(k) Submission

K162514 is an FDA 510(k) clearance for the Multichem A1c, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Technopath Manufacturing (Ballina, IE). The FDA issued a Cleared decision on October 26, 2016, 48 days after receiving the submission on September 8, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K162514 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2016
Decision Date	October 26, 2016
Days to Decision	48 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF