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FDA 510(k)

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator

K-Number: K162538 · 2016-11-17

ApplicantSiemens Healthcare Diagnostics
Decision Date2016-11-17
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162538. 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 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162538.

When did ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator receive FDA 510(k) clearance?

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162538.

Who is the listed applicant for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator?

The FDA product code for ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator is JIT.

Other records listing Siemens Healthcare Diagnostics as applicant

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PMA P930027Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P010007KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK261364Atellica CH Acetaminophen 2 (ACTM)PMA P930036KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSPMA P250026Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsK251998Atellica CH Diazo Total Bilirubin (D_TBil)

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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.K163544Lumipulse G ProlactinFujirebio 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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