CHOCOLATE AGAR W/COFACTOR— 510(k) K841144

Substantially Equivalent

Anaerobe Systems

FDA 510(k) clearance K841144 for CHOCOLATE AGAR W/COFACTOR, Substantially Equivalent on 1984-03-26. Applicant: Anaerobe Systems.

Clearance details

Applicant
Anaerobe Systems
Product code
Code JSG
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JSG

product code JSG
Malfunction
817
Total
817

Source: openFDA MAUDE database, through . 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.