STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ— 510(k) K843452

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K843452 for STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ, Substantially Equivalent on 1984-09-27. Applicant: Fisher Scientific Co., LLC.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1984-09-05
Decision date: 1984-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.