Who is the manufacturer of COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC?

Cobe Laboratories, Inc. filed the 510(k) submission for COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (K900105).

What is the FDA product code for COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC?

LKN. as a Class U device in the GU panel.

What is the regulatory pathway for COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC

K900105 · Cobe Laboratories, Inc. · LKN · Mar 22, 1991 · GU

Device Facts

Record ID	K900105
Device Name	COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
Applicant	Cobe Laboratories, Inc.
Product Code	LKN · GU
Decision Date	Mar 22, 1991
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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