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FDA 510(k)

NUCLEAR ANTIGENS

K-Number: K810592 · 1981-10-23

ApplicantAlpha Antigens, Inc.
Decision Date1981-10-23
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NUCLEAR ANTIGENS is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Antigens, Inc.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K810592. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLEAR ANTIGENS?

NUCLEAR ANTIGENS is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Alpha Antigens, Inc.. The 510(k) number is K810592.

When did NUCLEAR ANTIGENS receive FDA 510(k) clearance?

NUCLEAR ANTIGENS received FDA 510(k) clearance on 1981-10-23, under 510(k) number K810592.

Who is the listed applicant for NUCLEAR ANTIGENS?

The FDA 510(k) record lists Alpha Antigens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUCLEAR ANTIGENS?

The FDA product code for NUCLEAR ANTIGENS is LLL.

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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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