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FDA 510(k)

ST AIA-PACK DHEA-S CALIBRATOR SET

K-Number: K111762 · 2011-08-05

ApplicantTosoh Bioscience, Inc.
Decision Date2011-08-05
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK DHEA-S 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 2011-08-05 under 510(k) number K111762. 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 DHEA-S CALIBRATOR SET?

ST AIA-PACK DHEA-S CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2011-08-05. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K111762.

When did ST AIA-PACK DHEA-S CALIBRATOR SET receive FDA 510(k) clearance?

ST AIA-PACK DHEA-S CALIBRATOR SET received FDA 510(k) clearance on 2011-08-05, under 510(k) number K111762.

Who is the listed applicant for ST AIA-PACK DHEA-S 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 DHEA-S CALIBRATOR SET?

The FDA product code for ST AIA-PACK DHEA-S CALIBRATOR SET is JIT.

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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.

K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01K211199ST AIA-PACK BNP AssayK200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8K160113ST AIA-PACK hsE2 Calibrator SetK123131ST 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 AIK121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

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Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.

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.

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