LEUCO PREP
FDA 510(k) clearance K854093 · decided 1985-11-12
Clearance details
- K-number
- K854093
- Device name
- LEUCO PREP
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1985-10-07
- Decision date
- 1985-11-12
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JCF
- Device class
- 1
- Regulation number
- 864.8500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Paramus, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |