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FDA 510(k)

RHEUMAJET CRP

K-Number: K910686 · 1991-03-19

ApplicantBiokit USA, Inc.
Decision Date1991-03-19
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMAJET CRP is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K910686. 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 RHEUMAJET CRP?

RHEUMAJET CRP is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Biokit USA, Inc.. The 510(k) number is K910686.

When did RHEUMAJET CRP receive FDA 510(k) clearance?

RHEUMAJET CRP received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910686.

Who is the listed applicant for RHEUMAJET CRP?

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

What is the FDA product code for RHEUMAJET CRP?

The FDA product code for RHEUMAJET CRP is DCN.

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Other records listing Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK904311RHEUMAGEN ASO T-CONTROLK904312RHEUMAGEN CRP T-CONTROL

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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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