510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100433Substantially Equivalent

Immulite 2000 Cmv Igm, Immulite Cmv Igm Controls, and Immulite 200 Cmv Igm Adjustor Model L2kcm2, L2kcm6, Lcmc1, Lcmc2,

Siemens Healthcare Diagnostics Inc., West Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100433 is the FDA 510(k) clearance record for IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code LKQ (Antibody Igm,If, Cytomegalovirus Virus). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 2 recalls naming K100433.

Clearance record

Decision date
Received
(86 days to decision)
Product code
LKQ Antibody Igm,If, Cytomegalovirus Virus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Siemens Healthcare Diagnostics 1584 Enterprise Blvd., West Sacramento CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKQ

Trailing 12 months

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

FDA records show no clearances under product code LKQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKQ, 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