Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ST AIA-PACK hsE2 Calibrator Set

K-Number: K160113 · 2016-02-17

ApplicantTosoh Bioscience, Inc.
Decision Date2016-02-17
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK hsE2 Calibrator Set is a medical device manufactured by Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2016-02-17 under approval number K160113. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK hsE2 Calibrator Set?

ST AIA-PACK hsE2 Calibrator Set is a medical device that received FDA 510(k) clearance on 2016-02-17. It is manufactured by Tosoh Bioscience, Inc.. The 510(k) number is K160113.

When was ST AIA-PACK hsE2 Calibrator Set approved by the FDA?

ST AIA-PACK hsE2 Calibrator Set received FDA 510(k) clearance on 2016-02-17, under approval number K160113.

What company makes ST AIA-PACK hsE2 Calibrator Set?

ST AIA-PACK hsE2 Calibrator Set is manufactured by Tosoh Bioscience, Inc..

What is the FDA product code for ST AIA-PACK hsE2 Calibrator Set?

The FDA product code for ST AIA-PACK hsE2 Calibrator Set is JIT.

Other Devices by Tosoh Bioscience, Inc.

K211199ST AIA-PACK BNP Assay K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 PMA P910065Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Related Devices (Code: JIT)

K163078DC-UIBC-CALSekisui Diagnostics P.E.I., Inc. K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc. K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics K170938CalSet IGF-1Roche Diagnostics K170160Abbott ARCHITECT Free T3Abbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑