510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K946000Substantially Equivalent

Abuscreen Online(r) Calibrators

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

K946000 is the FDA 510(k) clearance record for ABUSCREEN ONLINE(R) CALIBRATORS, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code DKJ (Colorimetry, Salicylate). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K946000.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DKJ Colorimetry, Salicylate
Regulation
21 CFR 862.3830
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. Branchburg Township, Somerville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DKJ

Trailing 12 months

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

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