FDA 510(k)

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

K-Number: K051564 · 2005-08-22

Decision Date2005-08-22

Product CodeNQD

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2005-08-22 under 510(k) number K051564. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH?

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is Olympus America, Inc.. The 510(k) number is K051564.

When did OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH receive FDA 510(k) clearance?

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH received FDA 510(k) clearance on 2005-08-22, under 510(k) number K051564.

Who is the listed applicant for OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH?

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

What is the FDA product code for OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH?

The FDA product code for OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH is NQD.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Olympus America, Inc. as applicant

K111788ENDOEYE HD II K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN K073489OLYMPUS IGA REAGENT K073490OLYMPUS IGG REAGENT K073487OLYMPUS IGM REAGENT K062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

View all 149 devices →

Related Devices (Code: NQD)

K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH K173833CRP VarioSENTINEL CH. SpA K081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.

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.