510(k) K971239 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
GREINER VACUETTE BLOOD COLLECTION TUBE
| Applicant | Greiner America, Inc., Lake Mary FL, US |
| Decision | Substantially Equivalent, May 12, 1997 |
| Received | Apr 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2024 | Greiner Bio-One North America, Inc. VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged. Open, Classified |
JKA | None listed |
| Apr 26, 2016 | Greiner Bio-One North America, Inc. 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297
VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.