Who is the manufacturer of HELENA FACTOR V DEFICIENT SUBSTRATE?

Helena Laboratories filed the 510(k) submission for HELENA FACTOR V DEFICIENT SUBSTRATE (K792507).

What is the FDA product code for HELENA FACTOR V DEFICIENT SUBSTRATE?

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

What is the regulatory pathway for HELENA FACTOR V DEFICIENT SUBSTRATE?

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

Who can help prepare an FDA 510(k) submission like HELENA FACTOR V DEFICIENT SUBSTRATE?

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.

HELENA FACTOR V DEFICIENT SUBSTRATE

K792507 · Helena Laboratories · GGP · Dec 31, 1979 · Hematology

Device Facts

Record ID	K792507
Device Name	HELENA FACTOR V DEFICIENT SUBSTRATE
Applicant	Helena Laboratories
Product Code	GGP · Hematology
Decision Date	Dec 31, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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