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FDA 510(k)

CENTRIFI CHEM SYSTEM 400 ANALYZER

K-Number: K810596 · 1981-03-17

ApplicantUnion Carbide Corp.
Decision Date1981-03-17
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFI CHEM SYSTEM 400 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810596. 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 CENTRIFI CHEM SYSTEM 400 ANALYZER?

CENTRIFI CHEM SYSTEM 400 ANALYZER is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Union Carbide Corp.. The 510(k) number is K810596.

When did CENTRIFI CHEM SYSTEM 400 ANALYZER receive FDA 510(k) clearance?

CENTRIFI CHEM SYSTEM 400 ANALYZER received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810596.

Who is the listed applicant for CENTRIFI CHEM SYSTEM 400 ANALYZER?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIFI CHEM SYSTEM 400 ANALYZER?

The FDA product code for CENTRIFI CHEM SYSTEM 400 ANALYZER is JJE.

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Other records listing Union Carbide Corp. as applicant

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K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810129CENTRIFICHEM SYSTEM 500

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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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