CIBA CORNING 300 SERIES SYSTEM— 510(k) K933373

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K933373 for CIBA CORNING 300 SERIES SYSTEM, Substantially Equivalent on 1993-08-19. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant
Ciba Corning Diagnostics Corp.
Product code
Code JGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Medfield, MA, 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.