Cleared Traditional

ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set

K150270 · Tosoh Bioscience, Inc. · Chemistry

Oct 2015

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K150270 is an FDA 510(k) clearance for the ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on October 26, 2015, 264 days after receiving the submission on February 4, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number	K150270 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2015
Decision Date	October 26, 2015
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF