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SEPARATION TECHNOLOGY, INC.

Last updated May 30, 2026

Information

Country: US
Address: —
Website: ekfdiagnostics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 18005315535
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 195501127

Catalogue (29)

Device	Model / Reference	Registries	Class	Status
3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)	230-100D	FDA UDI	Class II	Active
ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes	270-109VL	FDA UDI	Class I	Active
UltraCrit	100-200	FDA UDI	Class II	Active
HemataChek Low Control	300-105	FDA UDI	Class II	Active
UltraCrit (Refurbished)	R100-200	FDA UDI	Class II	Active
HemataSTAT II Centrifuge	100-100	FDA UDI	Class II	Active
UltraChek Reference Controls Low	300-116	FDA UDI	Class II	Active
HemataSTAT II Centrifuge	100-133	FDA UDI	Class II	Active
HemataChek, Low, Normal, High Control	300-102	FDA UDI	Class II	Active
UltraCrit™ Cleaning Tools	320-111	FDA UDI	N/A	Active
Transparent Disp. Tube Tolders (for HemataSTAT, Cream 50/pkg)	230-100	FDA UDI	Class II	Active
UltraChek Reference Controls Normal	300-117	FDA UDI	Class II	Active
ClearCRIT® Plastic Capillary Tubes	270-106	FDA UDI	Class I	Active
ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes	270-109	FDA UDI	Class I	Active
HemataChek Normal Control	300-101	FDA UDI	Class II	Active
ClearCRIT® Plastic Capillary Tubes	270-107	FDA UDI	Class I	Active
ClearCrit Mylar®Coated Glass Capillary Tubes	270-108	FDA UDI	Class I	Active
Tube Sealant, Hemataseal	260-100	FDA UDI	Class II	Active
UltraCrit Loaner	100-201	FDA UDI	Class II	Active
UltraCrit Cuvettes	270-111	FDA UDI	Class II	Active
UltraCrit QC Cuvettes	270-112	FDA UDI	Class II	Active
HemataSTAT II Centrifuge (Refurbished)	R100-100	FDA UDI	Class II	Active
HemataChek, Low & Normal Control	300-103	FDA UDI	Class II	Active
HemataChek High Control	300-107	FDA UDI	Class II	Active
HemataChek, Normal & High Control	300-104	FDA UDI	Class II	Active
UltraChek Reference Controls High	300-118	FDA UDI	Class II	Active
UltraCrit Cleaning Tools	320-113	FDA UDI	N/A	Active
Hematastat H-70	K890849	FDA 510(k)	Class II	Active
Hematastat C-70b	K913128	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 13, 2013	Z-1367-2013	—	terminated	Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.