Cleared Traditional

IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR

K013984 · Diagnostic Products Corp. · Immunology
Mar 2002
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K013984 is an FDA 510(k) clearance for the IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 28, 2002, 115 days after receiving the submission on December 3, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K013984 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2001
Decision Date March 28, 2002
Days to Decision 115 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

Similar Devices — MOI System, Test, Immunological, Antigen, Tumor

All 27
Access BR Monitor
K240403 · Beckman Coulter, Inc. · May 2024
IMMULITE? 2000 BR-MA
K233946 · Siemens Healthcare Diagnostics Products, Ltd. · Mar 2024
Lumipulse G CA15-3
K192524 · Fujirebio Diagnostics,Inc. · Sep 2020
ADVIA Centaur BR
K193489 · Siemens Healthcare Diagnostics, Inc. · Feb 2020
ADVIA Centaur CA 15-3 assay
K192777 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
Elecsys CA 15-3 II
K181492 · Roche Diagnostics · Jun 2018