aBSI
K-Number: K191262 · 2019-08-05
ApplicantExini Diagnostics AB
Decision Date2019-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
aBSI is a medical device manufactured by Exini Diagnostics AB. It received FDA 510(k) clearance on 2019-08-05 under approval number K191262. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the aBSI?
aBSI is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Exini Diagnostics AB. The 510(k) number is K191262.
When was aBSI approved by the FDA?
aBSI received FDA 510(k) clearance on 2019-08-05, under approval number K191262.
What company makes aBSI?
aBSI is manufactured by Exini Diagnostics AB.
What is the FDA product code for aBSI?
The FDA product code for aBSI is LLZ.
Other Devices by Exini Diagnostics AB
Related Devices (Code: LLZ)
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.