510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K061990Substantially Equivalent

Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control

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

K061990 is the FDA 510(k) clearance record for DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL, a class II device, cleared for Dade Behring, Inc. on under FDA product code DCF (Albumin, 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 K061990.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DCF Albumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
Device class
Class II
Review panel
Immunology
Applicant
Dade Behring, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCF

Trailing 12 months

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

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