Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANTI-ENA TEST

K-Number: K831292 · 1983-07-18

ApplicantMeloy Laboratories, Inc.
Decision Date1983-07-18
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-ENA 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 1983-07-18 under 510(k) number K831292. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-ENA TEST?

ANTI-ENA TEST is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K831292.

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

ANTI-ENA TEST received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831292.

Who is the listed applicant for ANTI-ENA 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-ENA TEST?

The FDA product code for ANTI-ENA TEST is LKO.

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 VIIIK842247MELOY AUTOANTIBODY TEST SYSK820265ANA TEST (MOUSE LIVER SUBSTRATE)K820005TOTAL HEMOLYTIC COMPLEMENT TEST KIT

View all 15 devices →

Related Devices (Code: LKO)

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.

K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun USK083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01Phadia US, Inc.K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SAK022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741Rhigene, Inc.K000752RHIGENE MESACUP2 TEST- RNPRhigene, 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.

↑