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FDA 510(k)

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

K-Number: K172232 · 2019-06-12

ApplicantAms Diagnostics
Decision Date2019-06-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is the device name listed in this FDA 510(k) record. The listed applicant is Ams Diagnostics. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K172232. 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 LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Ams Diagnostics. The 510(k) number is K172232.

When did LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 receive FDA 510(k) clearance?

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 received FDA 510(k) clearance on 2019-06-12, under 510(k) number K172232.

Who is the listed applicant for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

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

What is the FDA product code for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

The FDA product code for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is JGS.

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

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