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FDA 510(k)

PLASMA EDGE System

K-Number: K240504 · 2024-06-12

ApplicantLamidey Noury Medical
Decision Date2024-06-12
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLASMA EDGE System is a medical device manufactured by Lamidey Noury Medical. It received FDA 510(k) clearance on 2024-06-12 under approval number K240504. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA EDGE System?

PLASMA EDGE System is a medical device that received FDA 510(k) clearance on 2024-06-12. It is manufactured by Lamidey Noury Medical. The 510(k) number is K240504.

When was PLASMA EDGE System approved by the FDA?

PLASMA EDGE System received FDA 510(k) clearance on 2024-06-12, under approval number K240504.

What company makes PLASMA EDGE System?

PLASMA EDGE System is manufactured by Lamidey Noury Medical.

What is the FDA product code for PLASMA EDGE System?

The FDA product code for PLASMA EDGE System is FAS.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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