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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 a medical device manufactured by Ams Diagnostics. It received FDA 510(k) clearance on 2019-06-12 under approval 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. It is manufactured by Ams Diagnostics. The 510(k) number is K172232.

When was LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 approved by the FDA?

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

What company makes LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is manufactured by Ams Diagnostics.

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.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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Official Source

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