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FDA 510(k)

Stat Profile Prime ES Comp Plus Analyzer System

K-Number: K191626 · 2019-08-16

ApplicantNova Biomedical Corporation
Decision Date2019-08-16
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Stat Profile Prime ES Comp Plus Analyzer System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2019-08-16 under approval number K191626. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stat Profile Prime ES Comp Plus Analyzer System?

Stat Profile Prime ES Comp Plus Analyzer System is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K191626.

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

Stat Profile Prime ES Comp Plus Analyzer System received FDA 510(k) clearance on 2019-08-16, under approval number K191626.

What company makes Stat Profile Prime ES Comp Plus Analyzer System?

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

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

The FDA product code for Stat Profile Prime ES Comp Plus Analyzer System is JFP.

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Other Devices by Nova Biomedical Corporation

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Related Devices (Code: JFP)

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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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