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FDA 510(k)

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

K-Number: K040332 · 2004-06-16

ApplicantArkray, Inc.
Decision Date2004-06-16
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K040332. 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 POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER?

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Arkray, Inc.. The 510(k) number is K040332.

When did POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER receive FDA 510(k) clearance?

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER received FDA 510(k) clearance on 2004-06-16, under 510(k) number K040332.

Who is the listed applicant for POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER?

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

What is the FDA product code for POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER?

The FDA product code for POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER is JJF.

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Related Devices (Code: JJF)

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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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