SPIFE A1AT kit
K-Number: K213396 · 2022-10-13
ApplicantHelena Laboratories, Corp.
Decision Date2022-10-13
Product CodeOBZ
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
SPIFE A1AT kit is a medical device manufactured by Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-10-13 under approval number K213396. The device is classified under product code OBZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SPIFE A1AT kit?
SPIFE A1AT kit is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Helena Laboratories, Corp.. The 510(k) number is K213396.
When was SPIFE A1AT kit approved by the FDA?
SPIFE A1AT kit received FDA 510(k) clearance on 2022-10-13, under approval number K213396.
What company makes SPIFE A1AT kit?
SPIFE A1AT kit is manufactured by Helena Laboratories, Corp..
What is the FDA product code for SPIFE A1AT kit?
The FDA product code for SPIFE A1AT kit is OBZ.
Other Devices by Helena Laboratories, Corp.
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.