Who is the manufacturer of FACTOR X DEFICIENT PLASMA, BLOD HUMAN?

Sigma Chemical Co. filed the 510(k) submission for FACTOR X DEFICIENT PLASMA, BLOD HUMAN (K843310).

What is the FDA product code for FACTOR X DEFICIENT PLASMA, BLOD HUMAN?

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

What is the regulatory pathway for FACTOR X DEFICIENT PLASMA, BLOD HUMAN?

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

Who can help prepare an FDA 510(k) submission like FACTOR X DEFICIENT PLASMA, BLOD HUMAN?

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.

FACTOR X DEFICIENT PLASMA, BLOD HUMAN

K843310 · Sigma Chemical Co. · GGP · Nov 19, 1984 · Hematology

Device Facts

Record ID	K843310
Device Name	FACTOR X DEFICIENT PLASMA, BLOD HUMAN
Applicant	Sigma Chemical Co.
Product Code	GGP · Hematology
Decision Date	Nov 19, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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