510(k) K983952 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
GREINER VACUETTE BLOOD COLLECTION TUBE
| Applicant | Greiner Meditech, Inc., Bel Air MD, US |
| Decision | Substantially Equivalent, Dec 28, 1998 |
| Received | Nov 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983952
| 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 |
| Nov 25, 2019 | Greiner Bio-One North America, Inc. 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 Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.