SoloSmart Injection Pen Adapter (SoloSmart®)
K-Number: K231820 · 2024-01-12
ApplicantBiocorp Production
Decision Date2024-01-12
Product CodeQOG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SoloSmart Injection Pen Adapter (SoloSmart®) is a medical device manufactured by Biocorp Production. It received FDA 510(k) clearance on 2024-01-12 under approval number K231820. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SoloSmart Injection Pen Adapter (SoloSmart®)?
SoloSmart Injection Pen Adapter (SoloSmart®) is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Biocorp Production. The 510(k) number is K231820.
When was SoloSmart Injection Pen Adapter (SoloSmart®) approved by the FDA?
SoloSmart Injection Pen Adapter (SoloSmart®) received FDA 510(k) clearance on 2024-01-12, under approval number K231820.
What company makes SoloSmart Injection Pen Adapter (SoloSmart®)?
SoloSmart Injection Pen Adapter (SoloSmart®) is manufactured by Biocorp Production.
What is the FDA product code for SoloSmart Injection Pen Adapter (SoloSmart®)?
The FDA product code for SoloSmart Injection Pen Adapter (SoloSmart®) is QOG.
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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.