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FDA 510(k)

DIMENSION AR CLINICAL CHEMISTRY SYSTEM

K-Number: K915106 · 1992-01-28

ApplicantDupont Medical Products
Decision Date1992-01-28
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION AR CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1992-01-28 under 510(k) number K915106. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION AR CLINICAL CHEMISTRY SYSTEM?

DIMENSION AR CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Dupont Medical Products. The 510(k) number is K915106.

When did DIMENSION AR CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

DIMENSION AR CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 1992-01-28, under 510(k) number K915106.

Who is the listed applicant for DIMENSION AR CLINICAL CHEMISTRY SYSTEM?

The FDA 510(k) record lists Dupont Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION AR CLINICAL CHEMISTRY SYSTEM?

The FDA product code for DIMENSION AR CLINICAL CHEMISTRY SYSTEM is JJE.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

View all 28 devices →

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco 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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