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)

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

K-Number: K844762 · 1985-06-04

ApplicantWellcome Diagnostics
Decision Date1985-06-04
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1985-06-04 under 510(k) number K844762. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51?

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 is a medical device that received FDA 510(k) clearance on 1985-06-04. The listed applicant is Wellcome Diagnostics. The 510(k) number is K844762.

When did MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 receive FDA 510(k) clearance?

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 received FDA 510(k) clearance on 1985-06-04, under 510(k) number K844762.

Who is the listed applicant for MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51?

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

What is the FDA product code for MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51?

The FDA product code for MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 is GTJ.

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 Wellcome Diagnostics 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.

K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01

View all 28 devices →

Related Devices (Code: GTJ)

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.

K952791DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems PreanalyticK915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK910210SLIDEX MENINGITE-KIT 5Vitek Systems, Inc.K885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome Diagnostics

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.

↑