INSURE PREGNANCY TEST— 510(k) K991515

Substantially Equivalent

Inbios Intl., Inc.

FDA 510(k) clearance K991515 for INSURE PREGNANCY TEST, Substantially Equivalent on 1999-05-28. Applicant: Inbios Intl., Inc..

Clearance details

Applicant: Inbios Intl., Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1999-04-30
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.