FDA 510(k)

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

K-Number: K022176 · 2002-12-03

ApplicantOrion Diagnostica, Div. Orion Corp.

Decision Date2002-12-03

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Div. Orion Corp.. It received FDA 510(k) clearance on 2002-12-03 under 510(k) number K022176. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257?

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 is a medical device that received FDA 510(k) clearance on 2002-12-03. The listed applicant is Orion Diagnostica, Div. Orion Corp.. The 510(k) number is K022176.

When did ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 receive FDA 510(k) clearance?

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 received FDA 510(k) clearance on 2002-12-03, under 510(k) number K022176.

Who is the listed applicant for ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257?

The FDA 510(k) record lists Orion Diagnostica, Div. Orion Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257?

The FDA product code for ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 is DCK.

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 Orion Diagnostica, Div. Orion Corp. as applicant

K031607ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL K971537PYLORISET EIA-G (68926)K942974PYLORISET DRY

Related Devices (Code: DCK)

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics K192028Yumizen C1200 CRPHORIBA ABX SAS K192118CRP VarioSENTINEL CH. SpA K191993Yumizen C1200 CRPHORIBA ABX SAS K160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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.