GCII AGAR WITH ISOVITALX(R) ENRICHMENT— 510(k) K945569

Substantially Equivalent

Becton Dickinson Microbiology Systems

FDA 510(k) clearance K945569 for GCII AGAR WITH ISOVITALX(R) ENRICHMENT, Substantially Equivalent on 1995-02-02. Applicant: Becton Dickinson Microbiology Systems.

Clearance details

Applicant: Becton Dickinson Microbiology Systems
Product code: Code JSO
Advisory panel: Microbiology
Date received: 1994-10-11
Decision date: 1995-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.