510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013984Substantially Equivalent

Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2kbr

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013984 is the FDA 510(k) clearance record for IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR, a class II device, cleared for Diagnostic Products Corp. on under FDA product code MOI (System, Test, Immunological, Antigen, Tumor). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 2 recalls naming K013984.

Clearance record

Decision date
Received
(115 days to decision)
Product code
MOI System, Test, Immunological, Antigen, Tumor
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOI

Trailing 12 months

FDA records hold no clearances under product code MOI in the trailing twelve months.

FDA records show no clearances under product code MOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260