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FDA 510(k)

SYNCHRON CX4-CE

K-Number: K904220 · 1990-10-15

ApplicantBeckman
Decision Date1990-10-15
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX4-CE is the device name listed in this FDA 510(k) record. The listed applicant is Beckman. It received FDA 510(k) clearance on 1990-10-15 under 510(k) number K904220. 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-CE?

SYNCHRON CX4-CE is a medical device that received FDA 510(k) clearance on 1990-10-15. The listed applicant is Beckman. The 510(k) number is K904220.

When did SYNCHRON CX4-CE receive FDA 510(k) clearance?

SYNCHRON CX4-CE received FDA 510(k) clearance on 1990-10-15, under 510(k) number K904220.

Who is the listed applicant for SYNCHRON CX4-CE?

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

What is the FDA product code for SYNCHRON CX4-CE?

The FDA product code for SYNCHRON CX4-CE is JJE.

Related Clinical Trials

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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Other records listing Beckman as applicant

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.

K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLK935362P-AMYLASE CONTROLK904219SYNCHRON CX 7 CLINICAL ANALYZERK893583BECKMAN CHOLINESTERASE REAGENT KIT

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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