510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053075Substantially Equivalent

N Antisera to Human Transferrin

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

K053075 is the FDA 510(k) clearance record for N ANTISERA TO HUMAN TRANSFERRIN, a class II device, cleared for Dade Behring, Inc. on under FDA product code DDG (Transferrin, 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 K053075.

Clearance record

Decision date
Received
(135 days to decision)
Product code
DDG Transferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5880
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 DDG

Trailing 12 months

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

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