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FDA 510(k)

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

K-Number: K051648 · 2006-01-31

ApplicantArkray, Inc.
Decision Date2006-01-31
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID 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 2006-01-31 under 510(k) number K051648. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS?

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS is a medical device that received FDA 510(k) clearance on 2006-01-31. The listed applicant is Arkray, Inc.. The 510(k) number is K051648.

When did SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS receive FDA 510(k) clearance?

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS received FDA 510(k) clearance on 2006-01-31, under 510(k) number K051648.

Who is the listed applicant for SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID 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 INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS?

The FDA product code for SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS is CGS.

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Related Devices (Code: CGS)

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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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