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FDA 510(k)

MODIFIED PK300 AUTOMATIC EIA ANALYZER

K-Number: K893768 · 1989-08-15

ApplicantOlympus Corp.
Decision Date1989-08-15
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED PK300 AUTOMATIC EIA 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 1989-08-15 under 510(k) number K893768. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED PK300 AUTOMATIC EIA ANALYZER?

MODIFIED PK300 AUTOMATIC EIA ANALYZER is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Olympus Corp.. The 510(k) number is K893768.

When did MODIFIED PK300 AUTOMATIC EIA ANALYZER receive FDA 510(k) clearance?

MODIFIED PK300 AUTOMATIC EIA ANALYZER received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893768.

Who is the listed applicant for MODIFIED PK300 AUTOMATIC EIA 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 MODIFIED PK300 AUTOMATIC EIA ANALYZER?

The FDA product code for MODIFIED PK300 AUTOMATIC EIA ANALYZER is JJF.

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Other records listing Olympus Corp. as applicant

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, 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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