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FDA 510(k)

ST AIA-PACK CYSTATIN C, MODEL 025217

K-Number: K093960 · 2010-09-14

ApplicantTosoh Bioscience, Inc.
Decision Date2010-09-14
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK CYSTATIN C, MODEL 025217 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 2010-09-14 under 510(k) number K093960. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK CYSTATIN C, MODEL 025217?

ST AIA-PACK CYSTATIN C, MODEL 025217 is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K093960.

When did ST AIA-PACK CYSTATIN C, MODEL 025217 receive FDA 510(k) clearance?

ST AIA-PACK CYSTATIN C, MODEL 025217 received FDA 510(k) clearance on 2010-09-14, under 510(k) number K093960.

Who is the listed applicant for ST AIA-PACK CYSTATIN C, MODEL 025217?

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 CYSTATIN C, MODEL 025217?

The FDA product code for ST AIA-PACK CYSTATIN C, MODEL 025217 is NDY.

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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: NDY)

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.

K242585Cystatin CSENTINEL CH. SpAK181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbHK161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)K111664DIAZYME CYSTATIN C POC TEST KITDiazyme LaboratoriesK093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKamiya Biomedical Co.

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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