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FDA 510(k)

SYNCHRON CX(TM)5 CLINICAL ANALYZER

K-Number: K881495 · 1988-06-01

ApplicantBeckman Instruments, Inc.
Decision Date1988-06-01
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX(TM)5 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 1988-06-01 under 510(k) number K881495. 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 CX(TM)5 CLINICAL ANALYZER?

SYNCHRON CX(TM)5 CLINICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1988-06-01. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K881495.

When did SYNCHRON CX(TM)5 CLINICAL ANALYZER receive FDA 510(k) clearance?

SYNCHRON CX(TM)5 CLINICAL ANALYZER received FDA 510(k) clearance on 1988-06-01, under 510(k) number K881495.

Who is the listed applicant for SYNCHRON CX(TM)5 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 CX(TM)5 CLINICAL ANALYZER?

The FDA product code for SYNCHRON CX(TM)5 CLINICAL ANALYZER is JJE.

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Other records listing Beckman Instruments, Inc. 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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.

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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