Product code JCF— Hematology
CST
- Classification name
- Lymphocyte Separation Medium
- Device class
- Class 1
- Regulation
- 21 CFR 864.8500
- Advisory panel
- Hematology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code JCF
FDA has cleared devices under product code JCF between 1981 and 1992, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1992
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1982
- 1981
Top applicants under product code JCF
Recent clearances under product code JCF
- K911731 — LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
- K902445 — LYMPHO SEP(TM)
- K891407 — LEUCOPREP CELL SEPARATION TUBE
- K874328 — L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
- K873185 — DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
- K872775 — LEUCOPREP BRAND TUBE
- K860354 — SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
- K854093 — LEUCO PREP
- K842818 — CST
- K842146 — HISTOPAQUE-1077
- K812947 — MONO-POLY RESOLVING MEDIUM
- K812411 — IMMUNO-CELL IMMUNO-SEP KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.