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FDA 510(k)

CRP-WELLCOTEST

K-Number: K771139 · 1977-07-14

ApplicantBurroughs Wellcome Co.
Decision Date1977-07-14
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRP-WELLCOTEST is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771139. 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 CRP-WELLCOTEST?

CRP-WELLCOTEST is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K771139.

When did CRP-WELLCOTEST receive FDA 510(k) clearance?

CRP-WELLCOTEST received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771139.

Who is the listed applicant for CRP-WELLCOTEST?

The FDA 510(k) record lists Burroughs Wellcome Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRP-WELLCOTEST?

The FDA product code for CRP-WELLCOTEST is DCN.

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Other records listing Burroughs Wellcome Co. as applicant

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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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