HCG MIDSTREAM PREGNANCY TEST— 510(k) K945568

Substantially Equivalent

Mizuho USA, Inc.

FDA 510(k) clearance K945568 for HCG MIDSTREAM PREGNANCY TEST, Substantially Equivalent on 1995-01-17. Applicant: Mizuho USA, Inc..

Clearance details

Applicant: Mizuho USA, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1994-11-10
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.