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)

BGM CELL CULTURE

K-Number: K943886 · 1994-11-28

ApplicantNeogenex
Decision Date1994-11-28
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BGM CELL CULTURE is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K943886. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BGM CELL CULTURE?

BGM CELL CULTURE is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Neogenex. The 510(k) number is K943886.

When did BGM CELL CULTURE receive FDA 510(k) clearance?

BGM CELL CULTURE received FDA 510(k) clearance on 1994-11-28, under 510(k) number K943886.

Who is the listed applicant for BGM CELL CULTURE?

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

What is the FDA product code for BGM CELL CULTURE?

The FDA product code for BGM CELL CULTURE is KIR.

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 Neogenex 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.

K965047MINK LUNG CELL CULTUREK960909H292 CELL CULTUREK943887HUMAN NEWBORN FORESKIN CELL CULTUREK943888MDCK CELL CULTUREK943884PRIMARY MONKEY KIDNEY CELL CULTUREK943890WI38 CELL CULTURE

View all 20 devices →

Related Devices (Code: KIR)

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.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, 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.

↑