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)

BION DIRECT IDENTIFICATION CONTROL SLIDE

K-Number: K890616 · 1989-02-17

ApplicantBion Ent., Ltd.
Decision Date1989-02-17
Product CodeLJG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BION DIRECT IDENTIFICATION CONTROL SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890616. The device is classified under product code LJG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BION DIRECT IDENTIFICATION CONTROL SLIDE?

BION DIRECT IDENTIFICATION CONTROL SLIDE is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K890616.

When did BION DIRECT IDENTIFICATION CONTROL SLIDE receive FDA 510(k) clearance?

BION DIRECT IDENTIFICATION CONTROL SLIDE received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890616.

Who is the listed applicant for BION DIRECT IDENTIFICATION CONTROL SLIDE?

The FDA 510(k) record lists Bion Ent., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BION DIRECT IDENTIFICATION CONTROL SLIDE?

The FDA product code for BION DIRECT IDENTIFICATION CONTROL SLIDE is LJG.

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 Bion Ent., Ltd. 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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894624MUMPS VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

View all 14 devices →

Related Devices (Code: LJG)

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.

K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc.K883569HISTO-CHECK GRAM NEGATIVE SLIDESVal Tech Diagnostics, Inc.K883568HISTO-CHECK ACID FAST SLIDESVal Tech Diagnostics, 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.

↑