510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062191Substantially Equivalent

Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models Kc515 and Kc516

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062191 is the FDA 510(k) clearance record for DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516, a class I device, cleared for Dade Behring, Inc. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K062191.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. 500 Gbc Dr.,, Newark DE
510(k) summary
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIF, 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