BIOMERIEUX HEMOLAB THROMBOMAT— 510(k) K925492

Name: FDA 510(k) clearance K925492
Creator: U.S. Food and Drug Administration
Published: 1993-02-03

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K925492 for BIOMERIEUX HEMOLAB THROMBOMAT, Substantially Equivalent on 1993-02-03. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1992-11-02
Decision date: 1993-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJS

view all

K253188 — CoaguChek XS Plus System2025-10-24
K251564 — microINR System2025-07-21
K243543 — microINR System2025-02-27
K230802 — Xprecia Prime Coagulation System2024-03-15
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14

More clearances from Biomerieux Vitek, Inc.

view all

K973819 — VIDAS D-DIMER (DD) ASSAY1998-03-10
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05
K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY1997-04-08
K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY1996-10-07

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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