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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) 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. The listed applicant is Helena Laboratories, Corp.. The 510(k) number is K213396.

When did SPIFE A1AT kit receive FDA 510(k) clearance?

SPIFE A1AT kit received FDA 510(k) clearance on 2022-10-13, under 510(k) number K213396.

Who is the listed applicant for SPIFE A1AT kit?

The FDA 510(k) record lists Helena Laboratories, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIFE A1AT kit?

The FDA product code for SPIFE A1AT kit is OBZ.

Other records listing Helena Laboratories, Corp. 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.

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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.

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