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FDA 510(k)

ANTI-MITOCHONDRIAL

K-Number: K771155 · 1977-08-04

ApplicantMeloy Laboratories, Inc.
Decision Date1977-08-04
Product CodeDBE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-MITOCHONDRIAL 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 1977-08-04 under 510(k) number K771155. The device is classified under product code DBE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-MITOCHONDRIAL?

ANTI-MITOCHONDRIAL is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K771155.

When did ANTI-MITOCHONDRIAL receive FDA 510(k) clearance?

ANTI-MITOCHONDRIAL received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771155.

Who is the listed applicant for ANTI-MITOCHONDRIAL?

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-MITOCHONDRIAL?

The FDA product code for ANTI-MITOCHONDRIAL is DBE.

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Other records listing Meloy Laboratories, Inc. as applicant

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Related Devices (Code: DBE)

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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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