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)

GCII AGAR WITH ISOVITALX(R) ENRICHMENT

K-Number: K945569 · 1995-02-02

ApplicantBecton Dickinson Microbiology Systems
Decision Date1995-02-02
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GCII AGAR WITH ISOVITALX(R) ENRICHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Microbiology Systems. It received FDA 510(k) clearance on 1995-02-02 under 510(k) number K945569. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GCII AGAR WITH ISOVITALX(R) ENRICHMENT?

GCII AGAR WITH ISOVITALX(R) ENRICHMENT is a medical device that received FDA 510(k) clearance on 1995-02-02. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K945569.

When did GCII AGAR WITH ISOVITALX(R) ENRICHMENT receive FDA 510(k) clearance?

GCII AGAR WITH ISOVITALX(R) ENRICHMENT received FDA 510(k) clearance on 1995-02-02, under 510(k) number K945569.

Who is the listed applicant for GCII AGAR WITH ISOVITALX(R) ENRICHMENT?

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

What is the FDA product code for GCII AGAR WITH ISOVITALX(R) ENRICHMENT?

The FDA product code for GCII AGAR WITH ISOVITALX(R) ENRICHMENT is JSO.

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 Becton Dickinson Microbiology Systems 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.

K993577CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISCK984631BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYK981517CEFDINIR, 5 UG, SENSI-DISCK980683TROVAFLOXACIN 10G, SENSI-DISCK974578GREPAFLOXACIN, 5 MG, SENSI-DISCK970333BACTEC MYCO/F LYTIC CULTURE VIALS

View all 33 devices →

Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, 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.

↑