Nova Primary Glucose Analyzer System
K-Number: K203549 · 2022-10-18
ApplicantNova Biomedical Corporation
Decision Date2022-10-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Nova Primary Glucose Analyzer System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2022-10-18 under approval number K203549. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nova Primary Glucose Analyzer System?
Nova Primary Glucose Analyzer System is a medical device that received FDA 510(k) clearance on 2022-10-18. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K203549.
When was Nova Primary Glucose Analyzer System approved by the FDA?
Nova Primary Glucose Analyzer System received FDA 510(k) clearance on 2022-10-18, under approval number K203549.
What company makes Nova Primary Glucose Analyzer System?
Nova Primary Glucose Analyzer System is manufactured by Nova Biomedical Corporation.
What is the FDA product code for Nova Primary Glucose Analyzer System?
The FDA product code for Nova Primary Glucose Analyzer System is CGA.
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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.