FDA Product Code
FDA Product Code JCF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8500
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911731 | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-12-15 | Traditional | PDF ↗ |
| K902445 | LYMPHO SEP(TM) | Icn Biomedicals, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K891407 | LEUCOPREP CELL SEPARATION TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-26 | Traditional | PDF ↗ |
| K874328 | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | E.I. Dupont DE Nemours & Co., Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K873185 | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | Dynal Biotech, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K872775 | LEUCOPREP BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-10-02 | Traditional | PDF ↗ |
| K860354 | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | Sepratech Corporation C/O Keller and Heckman | 1986-04-18 | Traditional | PDF ↗ |
| K854093 | LEUCO PREP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-11-12 | Traditional | PDF ↗ |
| K842818 | CST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-10-23 | Traditional | PDF ↗ |
| K842146 | HISTOPAQUE-1077 | Sigma Chemical Co. | 1984-07-27 | Traditional | PDF ↗ |
| K812947 | MONO-POLY RESOLVING MEDIUM | Flow Laboratories, Inc. | 1982-03-11 | Traditional | PDF ↗ |
| K812411 | IMMUNO-CELL IMMUNO-SEP KIT | Kallestad Laboratories, Inc. | 1981-11-10 | Traditional | PDF ↗ |
Product code JCF · Class I · Hematology. Data: openFDA.