SERUM HCG MICROASSAY— 510(k) K884430

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K884430 for SERUM HCG MICROASSAY, Substantially Equivalent on 1988-12-09. Applicant: Diamedix Corp..

Clearance details

Applicant: Diamedix Corp.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1988-10-21
Decision date: 1988-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.