Chrysalis Intelligence · Sponsors · Sebia

Sebia

Norcross, GA, US · 4 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

4

2021-11-12 → 2024-04-04

Last 12 months

0

Product codes

3

Most recent

2024-04-04

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DFH	Kappa, Antigen, Antiserum, Control	Class II	Immunology	2	2024-02-23
GKA	Abnormal Hemoglobin Quantitation	Class II	Hematology	1	2024-04-04
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Class II	Immunology	1	2021-11-12

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2024-04-04	K232027	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	GKA	Class II	Hematology
2024-02-23	K231601	FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2	DFH	Class II	Immunology
2022-11-18	K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	DFH	Class II	Immunology
2021-11-12	K203184	HYDRASHIFT 2/4 isatuximab	CFF	Class II	Immunology