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FDA 510(k)

OLYMPUS REPLY CHEMISTRY ANALYZER

K-Number: K882451 · 1988-09-08

ApplicantOlympus Corp.
Decision Date1988-09-08
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS REPLY CHEMISTRY 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 1988-09-08 under 510(k) number K882451. 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 REPLY CHEMISTRY ANALYZER?

OLYMPUS REPLY CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is Olympus Corp.. The 510(k) number is K882451.

When did OLYMPUS REPLY CHEMISTRY ANALYZER receive FDA 510(k) clearance?

OLYMPUS REPLY CHEMISTRY ANALYZER received FDA 510(k) clearance on 1988-09-08, under 510(k) number K882451.

Who is the listed applicant for OLYMPUS REPLY CHEMISTRY 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 REPLY CHEMISTRY ANALYZER?

The FDA product code for OLYMPUS REPLY CHEMISTRY ANALYZER is JJE.

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Other records listing Olympus Corp. as applicant

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K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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