ST AIA-PACK PROG III Calibrator Set— 510(k) K153417

Name: FDA 510(k) clearance K153417
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K153417 for ST AIA-PACK PROG III Calibrator Set, Substantially Equivalent on 2015-12-18. Applicant: Tosoh Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2015-11-25
Decision date: 2015-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K153417

K-number listed on FDA's recall record

Z-2282-2016 — Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.Class III·Terminated·Tosoh Bioscience, Inc.·20160607

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153417.

Data sourced from openFDA. This site is unofficial and independent of the FDA.