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FDA 510(k)

SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

K-Number: K071280 · 2007-06-01

ApplicantBeckman Coulter, Inc.
Decision Date2007-06-01
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS 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 2007-06-01 under 510(k) number K071280. 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 CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS?

SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS is a medical device that received FDA 510(k) clearance on 2007-06-01. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K071280.

When did SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS receive FDA 510(k) clearance?

SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS received FDA 510(k) clearance on 2007-06-01, under 510(k) number K071280.

Who is the listed applicant for SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS?

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 CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS?

The FDA product code for SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS 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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