DeviceClearance

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT— 510(k) K980855

Substantially Equivalent

Dpc Cirrus

FDA 510(k) clearance K980855 for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT, Substantially Equivalent on 1998-04-21. Applicant: Dpc Cirrus.

Clearance details

Applicant
Dpc Cirrus
Product code
Code DHX
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Randolph, NJ, US
Download summary PDFView on FDA.gov ↗

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