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 | December 15, 1992 |
| K902445 | icn biomedicals | LYMPHO SEP(TM) | August 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 | February 16, 1988 |
| K873185 | dynal biotech | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | November 4, 1987 |
| K872775 | bd becton dickinson vacutainer systems preanalytic | LEUCOPREP BRAND TUBE | October 2, 1987 |
| K860354 | sepratech corporation c/o keller and heckman | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | April 18, 1986 |
| K854093 | bd becton dickinson vacutainer systems preanalytic | LEUCO PREP | November 12, 1985 |
| K842818 | bd becton dickinson vacutainer systems preanalytic | CST | October 23, 1984 |
| K842146 | sigma chemical | HISTOPAQUE-1077 | July 27, 1984 |
| K812947 | flow laboratories | MONO-POLY RESOLVING MEDIUM | March 11, 1982 |
| K812411 | kallestad laboratories | IMMUNO-CELL IMMUNO-SEP KIT | November 10, 1981 |