TECHNICON C202 SYSTEM— 510(k) K791989

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K791989 for TECHNICON C202 SYSTEM, Substantially Equivalent on 1979-10-17. Applicant: Technicon Instruments Corp..

Clearance details

Applicant
Technicon Instruments Corp.
Product code
Code CGA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CGA

product code CGA
Death
2
Malfunction
1,816
Total
1,818

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.