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FDA 510(k)

MELOY AUTOANTIBODY TEST SYS

K-Number: K842247 · 1984-06-26

ApplicantMeloy Laboratories, Inc.
Decision Date1984-06-26
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MELOY AUTOANTIBODY TEST SYS 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 1984-06-26 under 510(k) number K842247. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MELOY AUTOANTIBODY TEST SYS?

MELOY AUTOANTIBODY TEST SYS is a medical device that received FDA 510(k) clearance on 1984-06-26. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K842247.

When did MELOY AUTOANTIBODY TEST SYS receive FDA 510(k) clearance?

MELOY AUTOANTIBODY TEST SYS received FDA 510(k) clearance on 1984-06-26, under 510(k) number K842247.

Who is the listed applicant for MELOY AUTOANTIBODY TEST SYS?

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 AUTOANTIBODY TEST SYS?

The FDA product code for MELOY AUTOANTIBODY TEST SYS is DBM.

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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 ASSAYK844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CULK841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIK831292ANTI-ENA TESTK820265ANA TEST (MOUSE LIVER SUBSTRATE)K820005TOTAL HEMOLYTIC COMPLEMENT TEST KIT

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Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, Inc.

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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