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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 the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) 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. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K160113.

When did ST AIA-PACK hsE2 Calibrator Set receive FDA 510(k) clearance?

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

Who is the listed applicant for ST AIA-PACK hsE2 Calibrator Set?

The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Tosoh Bioscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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