FDA 510(k)

aBSI

K-Number: K191262 · 2019-08-05

Decision Date2019-08-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

aBSI is the device name listed in this FDA 510(k) record. The listed applicant is Exini Diagnostics AB. It received FDA 510(k) clearance on 2019-08-05 under 510(k) 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. The listed applicant is Exini Diagnostics AB. The 510(k) number is K191262.

When did aBSI receive FDA 510(k) clearance?

aBSI received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191262.

Who is the listed applicant for aBSI?

The FDA 510(k) record lists Exini Diagnostics AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for aBSI?

The FDA product code for aBSI is LLZ.

Other records listing Exini Diagnostics AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220590aPROMISE X K211655aPROMISE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.