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FDA 510(k)

DEMAND ANALYZER SYSTEM

K-Number: K831477 · 1983-06-17

ApplicantWorthington Diagnostic Systems
Decision Date1983-06-17
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEMAND ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1983-06-17 under 510(k) number K831477. 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 DEMAND ANALYZER SYSTEM?

DEMAND ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K831477.

When did DEMAND ANALYZER SYSTEM receive FDA 510(k) clearance?

DEMAND ANALYZER SYSTEM received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831477.

Who is the listed applicant for DEMAND ANALYZER SYSTEM?

The FDA 510(k) record lists Worthington Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEMAND ANALYZER SYSTEM?

The FDA product code for DEMAND ANALYZER SYSTEM is JJE.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832749EASYTOUCH BUN REAGENT SETK832427EASYTOUCH TROMBOPLASTIN REAGENTK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832750EASYTOUCH HEMOGLOBIN REAGENT

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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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