Who is the manufacturer of PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES?

Biopool AB filed the 510(k) submission for PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES (K915163).

What is the FDA product code for PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES?

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

What is the regulatory pathway for PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES?

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

Who can help prepare an FDA 510(k) submission like PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES?

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.

PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES

K915163 · Biopool AB · GGP · Jan 6, 1992 · Hematology

Device Facts

Record ID	K915163
Device Name	PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
Applicant	Biopool AB
Product Code	GGP · Hematology
Decision Date	Jan 6, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

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