Who is the manufacturer of FIBRINOSTIKA FBDP MICROELISA SYSTEM?

Organon Teknika Corp. filed the 510(k) submission for FIBRINOSTIKA FBDP MICROELISA SYSTEM (K912876).

What is the FDA product code for FIBRINOSTIKA FBDP MICROELISA SYSTEM?

DAP. It is classified under 21 CFR 864.7320 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for FIBRINOSTIKA FBDP MICROELISA SYSTEM?

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

Who can help prepare an FDA 510(k) submission like FIBRINOSTIKA FBDP MICROELISA SYSTEM?

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.

FIBRINOSTIKA FBDP MICROELISA SYSTEM

K912876 · Organon Teknika Corp. · DAP · Oct 9, 1991 · Hematology

Device Facts

Record ID	K912876
Device Name	FIBRINOSTIKA FBDP MICROELISA SYSTEM
Applicant	Organon Teknika Corp.
Product Code	DAP · Hematology
Decision Date	Oct 9, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7320
Device Class	Class 2

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