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FDA 510(k)

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

K-Number: K994325 · 2000-01-12

ApplicantBeckman Coulter, Inc.
Decision Date2000-01-12
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR 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 2000-01-12 under 510(k) number K994325. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR?

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K994325.

When did SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR receive FDA 510(k) clearance?

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR received FDA 510(k) clearance on 2000-01-12, under 510(k) number K994325.

Who is the listed applicant for SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR?

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 SYSTEMS MICROALBUMIN CALIBRATOR?

The FDA product code for SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR is JIS.

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Related Devices (Code: JIS)

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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