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FDA 510(k)

ST AIA-PACK INTACT PTH ASSAY

K-Number: K063605 · 2007-06-21

ApplicantTosoh Bioscience, Inc.
Decision Date2007-06-21
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK INTACT PTH ASSAY 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 2007-06-21 under 510(k) number K063605. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK INTACT PTH ASSAY?

ST AIA-PACK INTACT PTH ASSAY is a medical device that received FDA 510(k) clearance on 2007-06-21. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K063605.

When did ST AIA-PACK INTACT PTH ASSAY receive FDA 510(k) clearance?

ST AIA-PACK INTACT PTH ASSAY received FDA 510(k) clearance on 2007-06-21, under 510(k) number K063605.

Who is the listed applicant for ST AIA-PACK INTACT PTH ASSAY?

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 INTACT PTH ASSAY?

The FDA product code for ST AIA-PACK INTACT PTH ASSAY is CEW.

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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: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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