STAPHYLOCOCCUS MED. 110— 510(k) K800156

Substantially Equivalent

Isle Media and Sterile Products, Inc.

FDA 510(k) clearance K800156 for STAPHYLOCOCCUS MED. 110, Substantially Equivalent on 1980-02-13. Applicant: Isle Media and Sterile Products, Inc..

Clearance details

Applicant: Isle Media and Sterile Products, Inc.
Product code: Code JSJ
Advisory panel: Microbiology
Date received: 1980-01-24
Decision date: 1980-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.