510(k) K081929 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
| Applicant | Greiner Bio-One North America, Inc., Baldwin MD, US |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Jul 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081929
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Greiner Bio-One North America, Inc. 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 Separat Open, Classified |
JKA | None listed |
| Jul 17, 2024 | Greiner Bio-One North America, Inc. VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100
red cap-yellow ring, non-ridged Open, Classified |
JKA | None listed |
| Aug 28, 2020 | Greiner Bio-One North America, Inc. VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.