Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TAGO DIFFU-GEN C-REACTIVE PROTEIN

K-Number: K841265 · 1984-05-22

ApplicantTago, Inc.
Decision Date1984-05-22
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TAGO DIFFU-GEN C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Tago, Inc.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841265. 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 TAGO DIFFU-GEN C-REACTIVE PROTEIN?

TAGO DIFFU-GEN C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Tago, Inc.. The 510(k) number is K841265.

When did TAGO DIFFU-GEN C-REACTIVE PROTEIN receive FDA 510(k) clearance?

TAGO DIFFU-GEN C-REACTIVE PROTEIN received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841265.

Who is the listed applicant for TAGO DIFFU-GEN C-REACTIVE PROTEIN?

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

What is the FDA product code for TAGO DIFFU-GEN C-REACTIVE PROTEIN?

The FDA product code for TAGO DIFFU-GEN C-REACTIVE PROTEIN is DCN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tago, 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.

K841734TAGO FIFFU-GEN, OROSOMUCOIDK834218DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -K840404DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNOK833129TAGO DIFFU-GEN-APOLIPOPROTEIN B-100K830611RA SCREENING TESTK830531MONO SCREENING TEST

View all 8 devices →

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.

↑