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-NUCLEAR ANTIBODY TEST KIT (ANA)

K-Number: K822681 · 1982-12-13

ApplicantAmico Lab, Inc.
Decision Date1982-12-13
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1982-12-13 under 510(k) number K822681. 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 ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)?

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) is a medical device that received FDA 510(k) clearance on 1982-12-13. The listed applicant is Amico Lab, Inc.. The 510(k) number is K822681.

When did ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) receive FDA 510(k) clearance?

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) received FDA 510(k) clearance on 1982-12-13, under 510(k) number K822681.

Who is the listed applicant for ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)?

The FDA 510(k) record lists Amico Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)?

The FDA product code for ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) is DHN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Amico Lab, 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.

K842662ANTI-EPSTEIN-BARR VIRUS KITK842530AMIZYME-EBV TEST KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842529AMIZYME-CMV KITK842661ANTI-CYTOMEGALOVIRUS KIT

View all 32 devices →

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.

↑