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)

PREMIER BLASTOMYCES

K-Number: K923859 · 1992-10-05

ApplicantMeridian Diagnostics, Inc.
Decision Date1992-10-05
Product CodeMJL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER BLASTOMYCES is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K923859. The device is classified under product code MJL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER BLASTOMYCES?

PREMIER BLASTOMYCES is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K923859.

When did PREMIER BLASTOMYCES receive FDA 510(k) clearance?

PREMIER BLASTOMYCES received FDA 510(k) clearance on 1992-10-05, under 510(k) number K923859.

Who is the listed applicant for PREMIER BLASTOMYCES?

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

What is the FDA product code for PREMIER BLASTOMYCES?

The FDA product code for PREMIER BLASTOMYCES is MJL.

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 Meridian Diagnostics, 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

View all 92 devices →

Related Devices (Code: MJL)

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.

K840201EPIDURAL CATHETER TRAYAries Medical, 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.

↑