510(k) K974811— ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL

Substantially Equivalent

Boston Biomedica, Inc.

Clearance details

Applicant: Boston Biomedica, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1997-12-23
Decision date: 1998-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, US

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.