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)

BBLCRYSTAL ANAEROBE ID SYSTEM

K-Number: K944528 · 1995-03-07

ApplicantBecton Dickinson Microbiology Systems
Decision Date1995-03-07
Product CodeJSP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBLCRYSTAL ANAEROBE ID SYSTEM 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 1995-03-07 under 510(k) number K944528. The device is classified under product code JSP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBLCRYSTAL ANAEROBE ID SYSTEM?

BBLCRYSTAL ANAEROBE ID SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K944528.

When did BBLCRYSTAL ANAEROBE ID SYSTEM receive FDA 510(k) clearance?

BBLCRYSTAL ANAEROBE ID SYSTEM received FDA 510(k) clearance on 1995-03-07, under 510(k) number K944528.

Who is the listed applicant for BBLCRYSTAL ANAEROBE ID SYSTEM?

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 BBLCRYSTAL ANAEROBE ID SYSTEM?

The FDA product code for BBLCRYSTAL ANAEROBE ID SYSTEM is JSP.

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: JSP)

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.

K945489LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945487LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945488LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONVitek Systems, Inc.K900996VITEK ANAEROBE IDENTIFICATION CARDVitek Systems, Inc.K881380B. FRAGTEXAmerican Biomedical Products, 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.

↑