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FDA 510(k)

OLYMPUS HIGH SPEED ANALYZER

K-Number: K830762 · 1983-04-12

ApplicantOlympus Corp.
Decision Date1983-04-12
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS HIGH SPEED ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830762. 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 OLYMPUS HIGH SPEED ANALYZER?

OLYMPUS HIGH SPEED ANALYZER is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Olympus Corp.. The 510(k) number is K830762.

When did OLYMPUS HIGH SPEED ANALYZER receive FDA 510(k) clearance?

OLYMPUS HIGH SPEED ANALYZER received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830762.

Who is the listed applicant for OLYMPUS HIGH SPEED ANALYZER?

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

What is the FDA product code for OLYMPUS HIGH SPEED ANALYZER?

The FDA product code for OLYMPUS HIGH SPEED ANALYZER is JJE.

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Other records listing Olympus Corp. 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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