SAS PREGNANCY STRIP— 510(k) K965253

Substantially Equivalent

Sascie

FDA 510(k) clearance K965253 for SAS PREGNANCY STRIP, Substantially Equivalent on 1997-02-18. Applicant: Sascie.

Clearance details

Applicant: Sascie
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1996-12-16
Decision date: 1997-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.