510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990409Substantially Equivalent

Ontrak Teststik for Morphine 2000 (M2k)

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

K990409 is the FDA 510(k) clearance record for ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K), a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DMY (Gas Chromatography, Morphine). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K990409.

Clearance record

Decision date
Received
(65 days to decision)
Product code
DMY Gas Chromatography, Morphine
Regulation
21 CFR 862.3640
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DMY

Trailing 12 months

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

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