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FDA 510(k)

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

K-Number: K091052 · 2010-01-15

ApplicantAbaxis, Inc.
Decision Date2010-01-15
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 2010-01-15 under 510(k) number K091052. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM?

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Abaxis, Inc.. The 510(k) number is K091052.

When did PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM receive FDA 510(k) clearance?

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM received FDA 510(k) clearance on 2010-01-15, under 510(k) number K091052.

Who is the listed applicant for PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM?

The FDA 510(k) record lists Abaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM?

The FDA product code for PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM is DCN.

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Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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