Product code JCF
- Device name
- Lymphocyte Separation Medium
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.8500
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911731 | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-12-15 |
| K902445 | LYMPHO SEP(TM) | Icn Biomedicals, Inc. | 1990-08-22 |
| K891407 | LEUCOPREP CELL SEPARATION TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-26 |
| K874328 | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | E.I. Dupont DE Nemours & Co., Inc. | 1988-02-16 |
| K873185 | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | Dynal Biotech, Inc. | 1987-11-04 |
| K872775 | LEUCOPREP BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-10-02 |
| K860354 | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | Sepratech Corporation C/O Keller and Heckman | 1986-04-18 |
| K854093 | LEUCO PREP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-11-12 |
| K842818 | CST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-10-23 |
| K842146 | HISTOPAQUE-1077 | Sigma Chemical Co. | 1984-07-27 |
| K812947 | MONO-POLY RESOLVING MEDIUM | Flow Laboratories, Inc. | 1982-03-11 |
| K812411 | IMMUNO-CELL IMMUNO-SEP KIT | Kallestad Laboratories, Inc. | 1981-11-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05407010126969 | TheraPEAK® T-VIVO® MEDIUM 5L BAG | Lonza Verviers | 2025-05-14 |
| 05407010125818 | X-VIVO 10 with Gent and Phenol Red, 1L | Lonza Verviers | 2025-02-10 |
| 00628451099024 | Lympholyte-H | Cedarlane Corporation | 2024-12-10 |
| 00628451099017 | Lympholyte-H | Cedarlane Corporation | 2024-12-10 |
| 00628451099499 | Lympholyte-H | Cedarlane Corporation | 2024-12-10 |
| 00628451099482 | Lympholyte-H | Cedarlane Corporation | 2024-12-10 |
| 00628451099048 | Lympholyte-H | Cedarlane Corporation | 2024-12-10 |
| 06284510990011 | Lympholyte-H | Cedarlane Corporation | 2022-12-08 |
| 06284510990028 | Lympholyte-H | Cedarlane Corporation | 2022-12-08 |
| 06284510990042 | Lympholyte-H | Cedarlane Corporation | 2022-12-08 |
| 06284510990486 | Lympholyte-H | Cedarlane Corporation | 2022-12-08 |
| 06284510990493 | Lympholyte-H | Cedarlane Corporation | 2022-12-08 |
| 07540207854158 | SepMate-15 | Stemcell Technologies Canada Inc | 2022-10-21 |
| 07540207854509 | SepMate-50 | Stemcell Technologies Canada Inc | 2022-10-21 |
| 05407010122756 | X-VIVO 15 w/o PR and Gentamicine 10L bag | Lonza Verviers | 2022-09-12 |
| 05407010122589 | X-VIVO 15 w/o Gentamycin and PR - 3L bag | Lonza Verviers | 2022-09-12 |
| 05407010122572 | X-Vivo10 w/o Gent, PR w/ Rec Transf, 10L | Lonza Verviers | 2022-09-12 |
| 05407010122565 | STD X-Vivo 15 w/o gentamicin and pr, 1L | Lonza Verviers | 2022-09-12 |
| 05407010122541 | X-Vivo 15 w/o gentamicin and pr, 5L | Lonza Verviers | 2022-09-06 |
| 05407010122558 | STD X-Vivo 15 w/o gentamicin and pr, 5L | Lonza Verviers | 2022-09-06 |
| 05407010122626 | X-Vivo15(04-744)contains rec tran 1L bag | Lonza Verviers | 2022-09-06 |
| 05407010122633 | X-Vivo15(04-744) contains rec transf, 1L | Lonza Verviers | 2022-09-06 |
| 05407010122640 | X-VIVO10(04-743) contains rec transf -1L | Lonza Verviers | 2022-09-06 |
| 05407010122657 | X-VIVO 10 w/o Gentamycin w/o PR 1L | Lonza Verviers | 2022-09-06 |
| 05407010122664 | X-VIVO 15 w/o Gentamycin and PR, 1 L | Lonza Verviers | 2022-09-06 |
| 10190302006835 | Dynabeads™ HLA Cell Prep™ II | THERMO FISHER SCIENTIFIC BALTICS UAB | 2018-07-03 |
| 10190302006842 | Dynabeads™ HLA Cell Prep™ II | THERMO FISHER SCIENTIFIC BALTICS UAB | 2018-07-03 |
| 30382903627616 | BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate | BECTON, DICKINSON AND COMPANY | 2016-08-22 |
| 30382903627609 | BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate | BECTON, DICKINSON AND COMPANY | 2016-08-22 |
| 30382903627531 | BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin | BECTON, DICKINSON AND COMPANY | 2016-08-22 |