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FDA 510(k)

SERO/TEX CRP TEST

K-Number: K821388 · 1982-07-02

ApplicantTexas Immunology, Inc.
Decision Date1982-07-02
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERO/TEX CRP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821388. 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 SERO/TEX CRP TEST?

SERO/TEX CRP TEST is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K821388.

When did SERO/TEX CRP TEST receive FDA 510(k) clearance?

SERO/TEX CRP TEST received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821388.

Who is the listed applicant for SERO/TEX CRP TEST?

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

What is the FDA product code for SERO/TEX CRP TEST?

The FDA product code for SERO/TEX CRP TEST is DCN.

Other records listing Texas Immunology, 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.

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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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