ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT— 510(k) K871308

Substantially Equivalent

Allelix, Inc.

FDA 510(k) clearance K871308 for ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT, Substantially Equivalent on 1987-06-11. Applicant: Allelix, Inc..

Clearance details

Applicant: Allelix, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1987-04-01
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4v 1p1, CA

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.