HCG PREGNANCY ONE STEP TEST STRIP— 510(k) K923123

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K923123 for HCG PREGNANCY ONE STEP TEST STRIP, Substantially Equivalent on 1992-09-09. Applicant: Tcpi, Inc..

Clearance details

Applicant: Tcpi, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1992-06-26
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.