510(k) K881568— WILKENS CHALGREN BROTH

Substantially Equivalent

Acumedia Manufacturers, Inc.

Clearance details

Applicant: Acumedia Manufacturers, Inc.
Product code: Code JSO
Advisory panel: Microbiology
Date received: 1988-04-11
Decision date: 1988-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

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.