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)

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

K-Number: K061408 · 2006-10-05

ApplicantEuroimmun Us, LLC
Decision Date2006-10-05
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, LLC. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K061408. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT?

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Euroimmun Us, LLC. The 510(k) number is K061408.

When did EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT receive FDA 510(k) clearance?

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT received FDA 510(k) clearance on 2006-10-05, under 510(k) number K061408.

Who is the listed applicant for EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT?

The FDA 510(k) record lists Euroimmun Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT?

The FDA product code for EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT is MVM.

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 Euroimmun Us, LLC 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.

K070789EUROIMMUN ANTI-CCP ELISAK061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITK070763EUROIMMUN ANA IFA: HEP-20-10K060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

Related Devices (Code: MVM)

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.

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia ABK183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, 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.

↑