510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032798Substantially Equivalent

Dimension Automated Hdl Cholesterol (Ahdl) Flex Reagent Cartridge (Df48a) Catalog # Df48a

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

K032798 is the FDA 510(k) clearance record for DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A, a class I device, cleared for Dade Behring, Inc. on under FDA product code JHM (Colorimetric Method, Lipoproteins). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K032798.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JHM Colorimetric Method, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
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 JHM

Trailing 12 months

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

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