JCF
12 FDA 510(k) clearances · Product code
82 daysmedian time to decision
142 days90th percentile
12clearances measured
FDA profile
- Official device name
- Lymphocyte Separation Medium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8500
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1994: 1 · 2018: 34 · 2019: 16 · 2024: 54 · 2025: 116 · 2026: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (K911731) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-12-15 |
| LYMPHO SEP(TM) (K902445) | Icn Biomedicals, Inc. | 1990-08-22 |
| LEUCOPREP CELL SEPARATION TUBE (K891407) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-26 |
| L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA (K874328) | E.I. Dupont DE Nemours & Co., Inc. | 1988-02-16 |
| DYNABEADS HLA CELL PREP II ISOLATION PRODUCT (K873185) | Dynal Biotech, Inc. | 1987-11-04 |
| LEUCOPREP BRAND TUBE (K872775) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-10-02 |
| SEPRACELL LYMPHOCYTE SEPARATION MEDIUM (K860354) | Sepratech Corporation C/O Keller and Heckman | 1986-04-18 |
| LEUCO PREP (K854093) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-11-12 |
| CST (K842818) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-10-23 |
| HISTOPAQUE-1077 (K842146) | Sigma Chemical Co. | 1984-07-27 |
| MONO-POLY RESOLVING MEDIUM (K812947) | Flow Laboratories, Inc. | 1982-03-11 |
| IMMUNO-CELL IMMUNO-SEP KIT (K812411) | Kallestad Laboratories, Inc. | 1981-11-10 |
Track JCF automatically
Every clearance here is in the API, with alerts when new ones post.