510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111904Substantially Equivalent

Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran

Ark Diagnostics Inc, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111904 is the FDA 510(k) clearance record for ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN, cleared for Ark Diagnostics, Inc. on under FDA product code LAO (Enzyme Immunoassay, Methotrexate). FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K111904.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LAO Enzyme Immunoassay, Methotrexate
Device class
Unclassified
Review panel
Unknown
Applicant
Ark Diagnostics, Inc. 1190 Bordeaux Dr., Sunnyvale CA
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