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

Name: FDA 510(k) clearance K980855
Creator: U.S. Food and Drug Administration
Published: 1998-04-21

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. Device class: 2.

Clearance details

Applicant: Dpc Cirrus
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1998-03-05
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, NJ, US

Download summary PDF View on FDA.gov ↗

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K970227 — IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER1997-04-08

Recalls naming K980855

K-number listed on FDA's recall record

Z-1679-2018 — IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEAClass II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980855.

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