ASSURE URINE HCG CONTROL— 510(k) K941130

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K941130 for ASSURE URINE HCG CONTROL, Substantially Equivalent on 1994-06-03. Applicant: Quantimetrix Corp..

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1994-03-09
Decision date: 1994-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hawthorne, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.