Panels › Clinical Chemistry › Product code GIM · Class 2
Tubes, Vacuum Sample, With Anticoagulant
Regulation 862.1675
0510(k)s in 12 months (39 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in GIM
| Company | 510(k)s | Recalls |
|---|---|---|
| Greiner Bio-One North America, Inc. | 0 | 6 |
| Sherwood Medical Industries | 5 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 0 |
| Becton, Dickinson and Company | 3 | 0 |
| Jelco Laboratories | 3 | 0 |
| Sherwood Medical Co. | 3 | 0 |
| Becton Dickinson Vacutainer Systems | 2 | 0 |
| Mbo Laboratories, Inc. | 2 | 0 |
| Organon, Inc. | 2 | 0 |
| Streck | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2025 | Greiner Bio-One North America, Inc. Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 Open, Classified |
GIM | K971221 |
| Aug 20, 2021 | Greiner Bio-One North America, Inc. Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged Terminated |
GIM | K971221 |
| May 6, 2021 | Greiner Bio-One North America, Inc. VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole Terminated |
GIM | K971221 |
| Mar 12, 2020 | Greiner Bio-One North America, Inc. VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. Terminated |
GIM | K971221 |
| Mar 8, 2017 | Streck Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck. Open, Classified |
GIM | K080552 |
| Aug 7, 2012 | Greiner Bio-One North America, Inc. 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334,
Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110.
Intended Use: Venous blood collection tubes. Terminated |
GIM | K971221 |
| Mar 30, 2012 | bioMerieux, Inc. BacT/ALERT Blood Collection Adapter
The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood colle Terminated |
GIM | K933939 |
| Sep 13, 2006 | Greiner Bio-One North America, Inc. Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Ste Terminated |
GIM | K971221 |
| Aug 10, 2004 | Greiner VACUETTE North America Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile Terminated |
GIM | K971221 |
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