Panels › Hematology › Product code JCF · Class 1
Lymphocyte Separation Medium
Regulation 864.8500
0510(k)s in 12 months (12 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in JCF
| Company | 510(k)s | Recalls |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 5 | 0 |
| Sigma-Aldrich Mfg LLC | 0 | 3 |
| Becton Dickinson & Company | 0 | 1 |
| Dynal Biotech, Inc. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Flow Laboratories, Inc. | 1 | 0 |
| Icn Biomedicals, Inc. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Sepratech Corporation C/O Keller and Heckman | 1 | 0 |
| Sigma Chemical Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2014 | Becton Dickinson & Company BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of Terminated |
JCF | K891407 K911731 |
| Mar 4, 2010 | Sigma-Aldrich Mfg LLC Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.
The product is for use in separatin Terminated |
JCF | None listed |
| Mar 4, 2010 | Sigma-Aldrich Mfg LLC Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.
This medium facilitate Terminated |
JCF | None listed |
| Mar 4, 2010 | Sigma-Aldrich Mfg LLC Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.
This medium facilitates rapid recovery of viable mononuclear ce Terminated |
JCF | None listed |
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