REP CHOLESTEROL PROFILE CONTROL-II— 510(k) K974609

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K974609 for REP CHOLESTEROL PROFILE CONTROL-II, Substantially Equivalent on 1998-01-06. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1997-12-10
Decision date: 1998-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, 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.