Who is the manufacturer of ORTHO FACTOR VII DEFICIENT PLASMA?

Ortho Diagnostic Systems, Inc. filed the 510(k) submission for ORTHO FACTOR VII DEFICIENT PLASMA (K883692).

What is the FDA product code for ORTHO FACTOR VII DEFICIENT PLASMA?

GJT. It is classified under 21 CFR 864.7290 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for ORTHO FACTOR VII DEFICIENT PLASMA?

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

Who can help prepare an FDA 510(k) submission like ORTHO FACTOR VII DEFICIENT PLASMA?

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.

ORTHO FACTOR VII DEFICIENT PLASMA

K883692 · Ortho Diagnostic Systems, Inc. · GJT · Nov 1, 1988 · Hematology

Device Facts

Record ID	K883692
Device Name	ORTHO FACTOR VII DEFICIENT PLASMA
Applicant	Ortho Diagnostic Systems, Inc.
Product Code	GJT · Hematology
Decision Date	Nov 1, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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