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FDA 510(k)

Stat Profile Prime Plus Analyzer System

K-Number: K221900 · 2023-09-29

ApplicantNova Biomedical Corporation
Decision Date2023-09-29
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Stat Profile Prime Plus Analyzer System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2023-09-29 under approval number K221900. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stat Profile Prime Plus Analyzer System?

Stat Profile Prime Plus Analyzer System is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K221900.

When was Stat Profile Prime Plus Analyzer System approved by the FDA?

Stat Profile Prime Plus Analyzer System received FDA 510(k) clearance on 2023-09-29, under approval number K221900.

What company makes Stat Profile Prime Plus Analyzer System?

Stat Profile Prime Plus Analyzer System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Stat Profile Prime Plus Analyzer System?

The FDA product code for Stat Profile Prime Plus Analyzer System is CHL.

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Related Devices (Code: CHL)

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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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