Cleared Special

TQ HBA1C GEN3

K102914 · Roche · Chemistry

Jan 2011

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K102914 is an FDA 510(k) clearance for the TQ HBA1C GEN3, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Roche (Indianapolos, US). The FDA issued a Cleared decision on January 20, 2011, 111 days after receiving the submission on October 1, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K102914 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2010
Decision Date	January 20, 2011
Days to Decision	111 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF