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FDA 510(k)

ANTI-NUCLEAR ANTIBODY TEST

K-Number: K791493 · 1979-09-24

ApplicantMeloy Laboratories, Inc.
Decision Date1979-09-24
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NUCLEAR ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meloy Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791493. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-NUCLEAR ANTIBODY TEST?

ANTI-NUCLEAR ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K791493.

When did ANTI-NUCLEAR ANTIBODY TEST receive FDA 510(k) clearance?

ANTI-NUCLEAR ANTIBODY TEST received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791493.

Who is the listed applicant for ANTI-NUCLEAR ANTIBODY TEST?

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

What is the FDA product code for ANTI-NUCLEAR ANTIBODY TEST?

The FDA product code for ANTI-NUCLEAR ANTIBODY TEST is DHN.

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Other records listing Meloy Laboratories, Inc. as applicant

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Related Devices (Code: DHN)

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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.

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