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)

ANA DETECT

K-Number: K030929 · 2003-05-02

ApplicantOrgentec Diagnostika GmbH
Decision Date2003-05-02
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec Diagnostika GmbH. It received FDA 510(k) clearance on 2003-05-02 under 510(k) number K030929. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA DETECT?

ANA DETECT is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Orgentec Diagnostika GmbH. The 510(k) number is K030929.

When did ANA DETECT receive FDA 510(k) clearance?

ANA DETECT received FDA 510(k) clearance on 2003-05-02, under 510(k) number K030929.

Who is the listed applicant for ANA DETECT?

The FDA 510(k) record lists Orgentec Diagnostika GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANA DETECT?

The FDA product code for ANA DETECT is LJM.

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 Orgentec Diagnostika GmbH 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.

K100499ORGENTEC RHEUMATOID FACTOR EIAK092399ANTI-MUTATED CITRULLINATED VIMENTIN EIA

Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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.

↑