Who is the manufacturer of PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765?

Sigma Chemical Co. filed the 510(k) submission for PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765 (K861048).

What is the FDA product code for PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765?

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

What is the regulatory pathway for PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765?

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

Who can help prepare an FDA 510(k) submission like PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765?

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.

PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765

K861048 · Sigma Chemical Co. · GGP · May 29, 1986 · Hematology

Device Facts

Record ID	K861048
Device Name	PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
Applicant	Sigma Chemical Co.
Product Code	GGP · Hematology
Decision Date	May 29, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765

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