UCD URINE SPECIMEN COLLECTOR— 510(k) K854173

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K854173 for UCD URINE SPECIMEN COLLECTOR, Substantially Equivalent on 1985-11-04. Applicant: Baker Instructions Corp..

Clearance details

Applicant
Baker Instructions Corp.
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Allentown, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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.