Cleared Traditional

ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR

K132664 · Siemens Healthcare Diagnostics, Inc. · Chemistry

Oct 2013

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K132664 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on October 16, 2013, 50 days after receiving the submission on August 27, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number	K132664 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2013
Decision Date	October 16, 2013
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF