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FDA 510(k)

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT

K-Number: K060935 · 2006-04-28

ApplicantBeckman Coulter, Inc.
Decision Date2006-04-28
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2006-04-28 under 510(k) number K060935. 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 SYNCHRON SYSTEMS CREATININE (CREA) REAGENT?

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT is a medical device that received FDA 510(k) clearance on 2006-04-28. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K060935.

When did SYNCHRON SYSTEMS CREATININE (CREA) REAGENT receive FDA 510(k) clearance?

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT received FDA 510(k) clearance on 2006-04-28, under 510(k) number K060935.

Who is the listed applicant for SYNCHRON SYSTEMS CREATININE (CREA) REAGENT?

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

What is the FDA product code for SYNCHRON SYSTEMS CREATININE (CREA) REAGENT?

The FDA product code for SYNCHRON SYSTEMS CREATININE (CREA) REAGENT is CGX.

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Related Devices (Code: CGX)

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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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