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FDA 510(k)

SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER

K-Number: K910185 · 1991-04-03

ApplicantBeckman Instruments, Inc.
Decision Date1991-04-03
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K910185. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER?

SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K910185.

When did SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER receive FDA 510(k) clearance?

SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910185.

Who is the listed applicant for SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER?

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

What is the FDA product code for SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER?

The FDA product code for SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER is JJE.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JJE)

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

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

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