SCRIPPS LABORATORIES HCG ONE-STEP— 510(k) K962906

Substantially Equivalent

Scripps Laboratories, Inc.

FDA 510(k) clearance K962906 for SCRIPPS LABORATORIES HCG ONE-STEP, Substantially Equivalent on 1996-08-23. Applicant: Scripps Laboratories, Inc..

Clearance details

Applicant: Scripps Laboratories, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1996-07-25
Decision date: 1996-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.