510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983387Substantially Equivalent

Ontrak Testcup and Teststik Controls

Roche Diagnostic Systems, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983387 is the FDA 510(k) clearance record for ONTRAK TESTCUP AND TESTSTIK CONTROLS, a class I device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K983387.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. Branchburg Township, Somerville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DIF

Trailing 12 months

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

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