510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190851Substantially Equivalent

HYDRASHIFT 2/4 daratumumab

Sebia, Inc., Norcross GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190851 is the FDA 510(k) clearance record for HYDRASHIFT 2/4 daratumumab, a class II device, cleared for Sebia on under FDA product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)). FDA records list 25 510(k) clearances for Sebia, from to . As of , FDA records show no recalls naming K190851.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Sebia 1705 Corporate Dr., Suite 400, Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFF

Trailing 12 months

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

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