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
K060628Substantially Equivalent

Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/dbi Calibrator

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

K060628 is the FDA 510(k) clearance record for DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR, a class II device, cleared for Dade Behring, Inc. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K060628.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dade Behring, Inc. Glasgow Business Community, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CIG

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