FDA 510(k)

ST AIA-PACK BNP Assay

K-Number: K211199 · 2021-11-08

Decision Date2021-11-08

Product CodeNBC

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK BNP Assay is a medical device manufactured by Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2021-11-08 under approval number K211199. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK BNP Assay?

ST AIA-PACK BNP Assay is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Tosoh Bioscience, Inc.. The 510(k) number is K211199.

When was ST AIA-PACK BNP Assay approved by the FDA?

ST AIA-PACK BNP Assay received FDA 510(k) clearance on 2021-11-08, under approval number K211199.

What company makes ST AIA-PACK BNP Assay?

ST AIA-PACK BNP Assay is manufactured by Tosoh Bioscience, Inc..

What is the FDA product code for ST AIA-PACK BNP Assay?

The FDA product code for ST AIA-PACK BNP Assay is NBC.

Other Devices by Tosoh Bioscience, Inc.

K160113ST AIA-PACK hsE2 Calibrator Set 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: NBC)

K192380ST AIA-PACK BNPFujirebio Diagnostics,Inc. K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc. K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics K232164Access NT-proBNPBeckman Coulter, Inc.

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.