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 AI— 510(k) K123131

Name: FDA 510(k) clearance K123131
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K123131 for 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 AI, Substantially Equivalent on 2013-02-08. Applicant: Tosoh Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2012-10-04
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

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