STANDARDS & ACCESSORIES FOR NOVA INSTRU— 510(k) K842873

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K842873 for STANDARDS & ACCESSORIES FOR NOVA INSTRU, Substantially Equivalent on 1984-10-05. Applicant: Diagnostic Chemicals, Ltd. (Usa).

Clearance details

Applicant
Diagnostic Chemicals, Ltd. (Usa)
Product code
Code JGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . 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.