FDA 510(k)

S-TEST C-REACTIVE PROTEIN (CRP)

K-Number: K083040 · 2009-01-30

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.

Decision Date2009-01-30

Product CodeDCN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

S-TEST C-REACTIVE PROTEIN (CRP) is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2009-01-30 under 510(k) number K083040. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-TEST C-REACTIVE PROTEIN (CRP)?

S-TEST C-REACTIVE PROTEIN (CRP) is a medical device that received FDA 510(k) clearance on 2009-01-30. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K083040.

When did S-TEST C-REACTIVE PROTEIN (CRP) receive FDA 510(k) clearance?

S-TEST C-REACTIVE PROTEIN (CRP) received FDA 510(k) clearance on 2009-01-30, under 510(k) number K083040.

Who is the listed applicant for S-TEST C-REACTIVE PROTEIN (CRP)?

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

What is the FDA product code for S-TEST C-REACTIVE PROTEIN (CRP)?

The FDA product code for S-TEST C-REACTIVE PROTEIN (CRP) is DCN.

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Related Devices (Code: DCN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.