MIT ONE STEP PREGNANCY TEST— 510(k) K953486

Substantially Equivalent

3c Diagnostics, Inc.

FDA 510(k) clearance K953486 for MIT ONE STEP PREGNANCY TEST, Substantially Equivalent on 1995-12-21. Applicant: 3c Diagnostics, Inc..

Clearance details

Applicant: 3c Diagnostics, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1995-07-25
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu, R.O.C., TW

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.