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FDA 510(k)

CENTRIFICHEM SYSTEM 500 ANALYZER

K-Number: K801139 · 1980-06-09

ApplicantUnion Carbide Corp.
Decision Date1980-06-09
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM SYSTEM 500 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 1980-06-09 under 510(k) number K801139. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFICHEM SYSTEM 500 ANALYZER?

CENTRIFICHEM SYSTEM 500 ANALYZER is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Union Carbide Corp.. The 510(k) number is K801139.

When did CENTRIFICHEM SYSTEM 500 ANALYZER receive FDA 510(k) clearance?

CENTRIFICHEM SYSTEM 500 ANALYZER received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801139.

Who is the listed applicant for CENTRIFICHEM SYSTEM 500 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 CENTRIFICHEM SYSTEM 500 ANALYZER?

The FDA product code for CENTRIFICHEM SYSTEM 500 ANALYZER is JJG.

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Other records listing Union Carbide Corp. as applicant

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Related Devices (Code: JJG)

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K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.

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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