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FDA 510(k)

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

K-Number: K011213 · 2001-05-16

ApplicantBeckman Coulter, Inc.
Decision Date2001-05-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM 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 2001-05-16 under 510(k) number K011213. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM?

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K011213.

When did MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 2001-05-16, under 510(k) number K011213.

Who is the listed applicant for MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM?

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 MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM?

The FDA product code for MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM is JGS.

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Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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