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FDA 510(k)

Stat Profile Prime Plus Analyzer System

K-Number: K180186 · 2018-08-23

ApplicantNova Biomedical Corporation
Decision Date2018-08-23
Product CodeGGZ
Advisory CommitteeHE
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 2018-08-23 under approval number K180186. The device is classified under product code GGZ. It was reviewed by the HE 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 2018-08-23. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K180186.

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

Stat Profile Prime Plus Analyzer System received FDA 510(k) clearance on 2018-08-23, under approval number K180186.

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 GGZ.

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Other Devices by Nova Biomedical Corporation

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Related Devices (Code: GGZ)

K200204Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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