GREINER VACUETTE BLOOD COLLECTION TUBE— 510(k) K983952

Clearance details

Applicant

Greiner Meditech, Inc.

Product code

Code JKA

Device class

Class 2

Regulation

21 CFR 862.1675

Advisory panel

Clinical Chemistry

Date received

1998-11-05

Decision date

1998-12-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bel Air, MD, US

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• K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes2026-03-13

• K992145 — ECOMED SCALP VEIN SET1999-10-14
• K992244 — GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE1999-07-26
• K991843 — GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE1999-06-25
• K982998 — GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE1998-10-21
• K982999 — GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE1998-10-16

Injury

455

Malfunction

26,686

Other

4

Total

27,145

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 →

• Z-0571-2026 — Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)Class II·Ongoing·Greiner Bio-One North America, Inc.·20250819
• Z-2375-2024 — VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridgedClass II·Ongoing·Greiner Bio-One North America, Inc.·20240514
• Z-0818-2020 — VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.Class II·Terminated·Greiner Bio-One North America, Inc.·20191125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983952.