510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061655Substantially Equivalent

Dimension Vista Flex Reagent Cartridges

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

K061655 is the FDA 510(k) clearance record for DIMENSION VISTA FLEX REAGENT CARTRIDGES, a class II device, cleared for Dade Behring, Inc. on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show 7 recalls naming K061655.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. Glasgow Business Community, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDP

Trailing 12 months
1 clearance under product code LDP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260