SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)— 510(k) K974108

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K974108 for SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE), Substantially Equivalent on 1997-11-26. Applicant: Quidel Corp..

Clearance details

Applicant: Quidel Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1997-10-31
Decision date: 1997-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.