510(k) K874328
- Device
- L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K874328
- Product code
- JCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-16
- Date received
- 1987-10-22
- Regulation
- 864.8500
- Classification name
- Lymphocyte Separation Medium
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD R KIMMELMAN
- Address
- Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898
FDA Registration Numbers#
- 2024375
- 3000178104
- 3030625683
- 3006158025
- 3005182159
- 3004450619
- 3009573214
- 2243072
- 3013221738
- 3013058950
- 8010134
- 1917413
- 1114298
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCF #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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