Who is the manufacturer of THE STAGO VIII DEFICIENT PLASMA KIT?

American Bioproducts Co. filed the 510(k) submission for THE STAGO VIII DEFICIENT PLASMA KIT (K892859).

What is the FDA product code for THE STAGO VIII DEFICIENT PLASMA KIT?

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

What is the regulatory pathway for THE STAGO VIII DEFICIENT PLASMA KIT?

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

Who can help prepare an FDA 510(k) submission like THE STAGO VIII DEFICIENT PLASMA KIT?

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.

THE STAGO VIII DEFICIENT PLASMA KIT

K892859 · American Bioproducts Co. · GGP · Jun 23, 1989 · Hematology

Device Facts

Record ID	K892859
Device Name	THE STAGO VIII DEFICIENT PLASMA KIT
Applicant	American Bioproducts Co.
Product Code	GGP · Hematology
Decision Date	Jun 23, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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