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FDA 510(k)

SYNCHRON CX3 DELTA

K-Number: K942676 · 1994-11-02

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-11-02
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX3 DELTA is the device name listed in this FDA 510(k) record. The listed applicant is Beckman-Diagnostic Systems Group. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K942676. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON CX3 DELTA?

SYNCHRON CX3 DELTA is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K942676.

When did SYNCHRON CX3 DELTA receive FDA 510(k) clearance?

SYNCHRON CX3 DELTA received FDA 510(k) clearance on 1994-11-02, under 510(k) number K942676.

Who is the listed applicant for SYNCHRON CX3 DELTA?

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

What is the FDA product code for SYNCHRON CX3 DELTA?

The FDA product code for SYNCHRON CX3 DELTA is JJF.

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Other records listing Beckman-Diagnostic Systems Group 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.

K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSK944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSK944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMK944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENTK934068BECKMAN DIRECT BILIRUBIN REAGENT

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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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