JCF — Lymphocyte Separation Medium Class I
FDA product code JCF covers "Lymphocyte Separation Medium", a Class I medical device regulated under 21 CFR 864.8500. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JCF
- Device Class
- Class I
- Regulation Number
- 864.8500
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K911731 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | Dec 15, 1992 |
| K902445 | Icn Biomedicals | LYMPHO SEP(TM) | Aug 22, 1990 |
| K891407 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCOPREP CELL SEPARATION TUBE | May 26, 1989 |
| K874328 | E.I. Dupont De Nemours And Co | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | Feb 16, 1988 |
| K873185 | Dynal Biotech | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | Nov 4, 1987 |
| K872775 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCOPREP BRAND TUBE | Oct 2, 1987 |
| K860354 | Sepratech Corporation C/O Keller And Heckman | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | Apr 18, 1986 |
| K854093 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCO PREP | Nov 12, 1985 |
| K842818 | Bd Becton Dickinson Vacutainer Systems Preanalytic | CST | Oct 23, 1984 |
| K842146 | Sigma Chemical | HISTOPAQUE-1077 | Jul 27, 1984 |
| K812947 | Flow Laboratories | MONO-POLY RESOLVING MEDIUM | Mar 11, 1982 |
| K812411 | Kallestad Laboratories | IMMUNO-CELL IMMUNO-SEP KIT | Nov 10, 1981 |