FDA 510(k)

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS

K-Number: K033058 · 2004-01-30

Decision Date2004-01-30

Product CodeCGX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-01-30 under 510(k) number K033058. 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 CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS?

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-01-30. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K033058.

When did CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS receive FDA 510(k) clearance?

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS received FDA 510(k) clearance on 2004-01-30, under 510(k) number K033058.

Who is the listed applicant for CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS?

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

What is the FDA product code for CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS?

The FDA product code for CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS is CGX.

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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.