510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110446Substantially Equivalent

Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat Control Set B, and Roche Oral Fluid

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

K110446 is the FDA 510(k) clearance record for ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID, a class II device, cleared for Roche Diagnostics on under FDA product code DKZ (Enzyme Immunoassay, Amphetamine). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K110446.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DKZ Enzyme Immunoassay, Amphetamine
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DKZ

Trailing 12 months

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

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