510(k) K960857 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
| Applicant | Greiner America, Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | Mar 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2026 | Greiner Bio-One North America, Inc. Brand Name: VACUETTE
Product Name: LH Lithium Heparin Separator
Model/Catalog Number: 454008P
Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 7 Open, Classified |
JKA | None listed |
| Dec 9, 2021 | Greiner Bio-One North America, Inc. greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P Terminated |
JKA | None listed |
| Feb 22, 2012 | Greiner Bio-One North America, Inc. LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110.
Venous blood collection tubes. Terminated |
JKA | None listed |
| Dec 16, 2010 | Greiner Bio-One North America, Inc. Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC.
Venous blood collection tubes. Terminated |
JKA | None listed |
| Nov 7, 2008 | Greiner Bio-One North America, Inc. VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bi Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.