FIBRI-PREST AUTOMATE HA34— 510(k) K840211

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K840211 for FIBRI-PREST AUTOMATE HA34, Substantially Equivalent on 1984-03-02. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1984-01-19
Decision date: 1984-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQJ

K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL2025-07-24
K073367 — HEMOSIL FIBRINOGEN-C2007-12-27
K050928 — DADE THROMBIN REAGENT2005-06-29
K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)1997-10-09
K970189 — FIF TM1997-05-21

More clearances from Wellcome Diagnostics

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K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC511990-01-11
K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 501989-02-16
K875311 — WELLCOZYME HSV WZO21988-08-03

Recalls naming K840211

K-number listed on FDA's recall record

Z-2476-2025 — STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.Class II·Ongoing·Diagnostica Stago, Inc.·20250721

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K840211.

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