510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233454Substantially Equivalent

ONLINE TDM Methotrexate

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233454 is the FDA 510(k) clearance record for ONLINE TDM Methotrexate, cleared for Roche Diagnostics Operations on under FDA product code LAO (Enzyme Immunoassay, Methotrexate). FDA records list 465 510(k) clearances for ROCHE DIAGNOSTICS GMBH, from to . As of , FDA records show no recalls naming K233454.

Clearance record

Decision date
Received
(123 days to decision)
Product code
LAO Enzyme Immunoassay, Methotrexate
Device class
Unclassified
Review panel
Unknown
Applicant
Roche Diagnostics Operations 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
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