STA - LIATEST VWF TEST KIT— 510(k) K962675

Name: FDA 510(k) clearance K962675
Creator: U.S. Food and Drug Administration
Published: 1996-10-25

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K962675 for STA - LIATEST VWF TEST KIT, Substantially Equivalent on 1996-10-25. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1996-07-09
Decision date: 1996-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K962675

K-number listed on FDA's recall record

Z-0951-2013 — Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asni¿res sur Seine (France) Coagulation AssayClass II·Terminated·Diagnostica Stago, Inc.·20130128

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962675.

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