510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100910Substantially Equivalent

Immulite 2000 3Gallergy Specific Ige Assay Kit, Model L2kun6

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

K100910 is the FDA 510(k) clearance record for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6, a class II device, cleared for Siemens Medical Solutions Diagnostics on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K100910.

Clearance record

Decision date
Received
(405 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Dr., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DHB

Trailing 12 months
7 clearances under product code DHB in the twelve months to November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DHB, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20262
August 20260
September 20261
October 20260
November 20260