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FDA 510(k)

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

K-Number: K050652 · 2005-04-06

ApplicantArkray, Inc.
Decision Date2005-04-06
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2005-04-06 under 510(k) number K050652. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTCHEM II CREATININE, AMYLASE & ALP TESTS?

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS is a medical device that received FDA 510(k) clearance on 2005-04-06. The listed applicant is Arkray, Inc.. The 510(k) number is K050652.

When did SPOTCHEM II CREATININE, AMYLASE & ALP TESTS receive FDA 510(k) clearance?

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS received FDA 510(k) clearance on 2005-04-06, under 510(k) number K050652.

Who is the listed applicant for SPOTCHEM II CREATININE, AMYLASE & ALP TESTS?

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 SPOTCHEM II CREATININE, AMYLASE & ALP TESTS?

The FDA product code for SPOTCHEM II CREATININE, AMYLASE & ALP TESTS is CGX.

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Related Devices (Code: CGX)

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.

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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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