Who is the manufacturer of DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

Baxter Diagnostics, Inc. filed the 510(k) submission for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (K920895).

What is the FDA product code for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

MIF. It is classified under 21 CFR 864.7320 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

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

Who can help prepare an FDA 510(k) submission like DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

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.

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

K920895 · Baxter Diagnostics, Inc. · MIF · Jun 4, 1992 · Hematology

Device Facts

Record ID	K920895
Device Name	DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA
Applicant	Baxter Diagnostics, Inc.
Product Code	MIF · Hematology
Decision Date	Jun 4, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7320
Device Class	Class 2

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