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FDA 510(k)

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL

K-Number: K844678 · 1985-01-04

ApplicantMeloy Laboratories, Inc.
Decision Date1985-01-04
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL 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 1985-01-04 under 510(k) number K844678. 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 MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL?

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL is a medical device that received FDA 510(k) clearance on 1985-01-04. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K844678.

When did MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL receive FDA 510(k) clearance?

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL received FDA 510(k) clearance on 1985-01-04, under 510(k) number K844678.

Who is the listed applicant for MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL?

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 MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL?

The FDA product code for MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL is DHN.

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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.

K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAYK841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIK842247MELOY AUTOANTIBODY TEST SYSK831292ANTI-ENA TESTK820265ANA TEST (MOUSE LIVER SUBSTRATE)K820005TOTAL HEMOLYTIC COMPLEMENT TEST KIT

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Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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