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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1992 | K911731 | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR Bd Becton Dickinson Vacutainer Systems Preanalytic | JCF |
| Aug 22, 1990 | K902445 | LYMPHO SEP(TM) Icn Biomedicals, Inc. | JCF |
| May 26, 1989 | K891407 | LEUCOPREP CELL SEPARATION TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic | JCF |
| Feb 16, 1988 | K874328 | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA E.I. Dupont DE Nemours & Co., Inc. | JCF |
| Nov 4, 1987 | K873185 | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT Dynal Biotech, Inc. | JCF |
| Oct 2, 1987 | K872775 | LEUCOPREP BRAND TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic | JCF |
| Apr 18, 1986 | K860354 | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM Sepratech Corporation C/O Keller and Heckman | JCF |
| Nov 12, 1985 | K854093 | LEUCO PREP Bd Becton Dickinson Vacutainer Systems Preanalytic | JCF |
| Oct 23, 1984 | K842818 | CST Bd Becton Dickinson Vacutainer Systems Preanalytic | JCF |
| Jul 27, 1984 | K842146 | HISTOPAQUE-1077 Sigma Chemical Co. | JCF |
| Mar 11, 1982 | K812947 | MONO-POLY RESOLVING MEDIUM Flow Laboratories, Inc. | JCF |
| Nov 10, 1981 | K812411 | IMMUNO-CELL IMMUNO-SEP KIT Kallestad Laboratories, Inc. | JCF |
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