GC II AGAR WITH ISOVITALEX— 510(k) K932882

Substantially Equivalent

Becton Dickinson Microbiology Systems

FDA 510(k) clearance K932882 for GC II AGAR WITH ISOVITALEX, Substantially Equivalent on 1993-09-24. Applicant: Becton Dickinson Microbiology Systems.

Clearance details

Applicant: Becton Dickinson Microbiology Systems
Product code: Code JSO
Advisory panel: Microbiology
Date received: 1993-06-14
Decision date: 1993-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

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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.