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FDA 510(k)

METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM

K-Number: K863840 · 1986-11-05

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1986-11-05
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K863840. 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 METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM?

METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K863840.

When did METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM receive FDA 510(k) clearance?

METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM received FDA 510(k) clearance on 1986-11-05, under 510(k) number K863840.

Who is the listed applicant for METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM?

The FDA product code for METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM is JJE.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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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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