VON WILLEBRAND REAGENT— 510(k) K972116

Name: FDA 510(k) clearance K972116
Creator: U.S. Food and Drug Administration
Published: 1997-07-25

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K972116 for VON WILLEBRAND REAGENT, Substantially Equivalent on 1997-07-25. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1997-06-05
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

view all

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

More clearances from Behring Diagnostics, Inc.

view all

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.