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FDA 510(k)

HUMAN IGG-ALBUMIN TEST KIT

K-Number: K811178 · 1981-05-15

ApplicantMeloy Laboratories, Inc.
Decision Date1981-05-15
Product CodeCJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN IGG-ALBUMIN TEST KIT 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 1981-05-15 under 510(k) number K811178. The device is classified under product code CJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN IGG-ALBUMIN TEST KIT?

HUMAN IGG-ALBUMIN TEST KIT is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K811178.

When did HUMAN IGG-ALBUMIN TEST KIT receive FDA 510(k) clearance?

HUMAN IGG-ALBUMIN TEST KIT received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811178.

Who is the listed applicant for HUMAN IGG-ALBUMIN TEST KIT?

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 HUMAN IGG-ALBUMIN TEST KIT?

The FDA product code for HUMAN IGG-ALBUMIN TEST KIT is CJQ.

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Other records listing Meloy Laboratories, Inc. 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

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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