DeviceClearance

WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191— 510(k) K053131

Substantially Equivalent

Wako Chemicals USA, Inc.

FDA 510(k) clearance K053131 for WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191, Substantially Equivalent on 2005-12-30. Applicant: Wako Chemicals USA, Inc..

Clearance details

Applicant
Wako Chemicals USA, Inc.
Product code
Code JFM
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Richmond, VA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.