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FDA 510(k)

LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)

K-Number: K855057 · 1986-02-26

ApplicantBehring Diagnostics, Inc.
Decision Date1986-02-26
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-02-26 under 510(k) number K855057. 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 LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)?

LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K855057.

When did LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) receive FDA 510(k) clearance?

LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855057.

Who is the listed applicant for LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)?

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

What is the FDA product code for LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)?

The FDA product code for LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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