DRX QT. HCG— 510(k) K991532

Substantially Equivalent

Metrika, Inc.

FDA 510(k) clearance K991532 for DRX QT. HCG, Substantially Equivalent on 1999-09-17. Applicant: Metrika, Inc..

Clearance details

Applicant: Metrika, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1999-05-03
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.