SeraQuest HSV Type 2 Specific IgG— 510(k) K152353

Substantially Equivalent

Quest International, Inc.

FDA 510(k) clearance K152353 for SeraQuest HSV Type 2 Specific IgG, Substantially Equivalent on 2016-05-13. Applicant: Quest International, Inc..

Clearance details

Applicant: Quest International, Inc.
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2015-08-20
Decision date: 2016-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

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.