510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K994165Substantially Equivalent

Ontrak Teststik 3 for Cocaine/morphine/thc,cat. 1118595

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

K994165 is the FDA 510(k) clearance record for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K994165.

Clearance record

Decision date
Received
(120 days to decision)
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation
21 CFR 862.3250
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 DIO

Trailing 12 months

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

FDA records show no clearances under product code DIO in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260