SeraQuest Herpes Type 1 Specific IgG— 510(k) K162276

Substantially Equivalent

Quest International, Inc.

FDA 510(k) clearance K162276 for SeraQuest Herpes Type 1 Specific IgG, Substantially Equivalent on 2016-10-01. Applicant: Quest International, Inc..

Clearance details

Applicant: Quest International, Inc.
Product code: Code MXJ
Advisory panel: Microbiology
Date received: 2016-08-12
Decision date: 2016-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXJ

product code MXJ

Injury: 139
Total: 139

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.