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FDA 510(k)

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

K-Number: K973692 · 1998-02-09

ApplicantUnited Biotech, Inc.
Decision Date1998-02-09
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K973692. 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 UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE?

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is United Biotech, Inc.. The 510(k) number is K973692.

When did UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE received FDA 510(k) clearance on 1998-02-09, under 510(k) number K973692.

Who is the listed applicant for UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE?

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

What is the FDA product code for UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE?

The FDA product code for UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE is DCK.

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Other records listing United Biotech, Inc. as applicant

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K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973155UBI MAGIWEL OPIATE METABOLITESK973156UBI MAGIWEL COCAINE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITESK962211UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

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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

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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