VON WILLEBRAND FACTOR ASSAY— 510(k) K802356

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K802356 for VON WILLEBRAND FACTOR ASSAY, Substantially Equivalent on 1980-12-01. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1980-09-26
Decision date: 1980-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

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 Bio/Data Corp.

K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C2000-07-12
K943153 — MICROSAMPLE COAGULATION ANALYZER1995-03-24
K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C1989-06-23
K881150 — KINETIC FIBRINOGEN ASSAY1988-03-28
K873382 — PLATELET EXTRACT REAGENT1987-11-20

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