510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781381Substantially Equivalent

Emit Methatrexate Assay

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781381 is the FDA 510(k) clearance record for EMIT METHATREXATE ASSAY, cleared for Dade Behring, Inc. on under FDA product code LAO (Enzyme Immunoassay, Methotrexate). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K781381.

Clearance record

Decision date
Received
(60 days to decision)
Product code
LAO Enzyme Immunoassay, Methotrexate
Device class
Unclassified
Review panel
Unknown
Applicant
Dade Behring, Inc. P.O. Box 6101, Newark DE
Third party review
No

Clearances, product code LAO

Trailing 12 months

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

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