ONE-STEP DIPSTICK PREGNANCY TEST— 510(k) K964536

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K964536 for ONE-STEP DIPSTICK PREGNANCY TEST, Substantially Equivalent on 1997-02-11. Applicant: Teco Diagnostics.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1996-11-12
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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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.