DADE FACTOR VIII CHROMOGENIC ASSAY— 510(k) K884544

Name: FDA 510(k) clearance K884544
Creator: U.S. Food and Drug Administration
Published: 1988-12-30

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K884544 for DADE FACTOR VIII CHROMOGENIC ASSAY, Substantially Equivalent on 1988-12-30. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1988-10-31
Decision date: 1988-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K884544

K-number listed on FDA's recall record

Z-0468-2016 — Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor DeficiencyClass II·Terminated·Siemens Healthcare Diagnostics, Inc.·20151119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884544.

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