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FDA 510(k)

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

K-Number: K031607 · 2003-10-10

ApplicantOrion Diagnostica, Div. Orion Corp.
Decision Date2003-10-10
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL 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 2003-10-10 under 510(k) number K031607. 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 QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL?

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Orion Diagnostica, Div. Orion Corp.. The 510(k) number is K031607.

When did ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL receive FDA 510(k) clearance?

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL received FDA 510(k) clearance on 2003-10-10, under 510(k) number K031607.

Who is the listed applicant for ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL?

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 QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL?

The FDA product code for ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL 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.

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Other records listing Orion Diagnostica, Div. Orion Corp. 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.

K022176ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257K971537PYLORISET EIA-G (68926)K942974PYLORISET DRY

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

Official Source

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