510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081249Substantially Equivalent

Dimension Vista System A2mac Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem

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

K081249 is the FDA 510(k) clearance record for DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM, a class II device, cleared for Dade Behring, Inc. on under FDA product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K081249.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
Device class
Class II
Review panel
Immunology
Applicant
Dade Behring, Inc. 500 Gbc Dr., Mailstop 514, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DEB

Trailing 12 months

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

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