510(k) K873185
- Device
- DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
- Applicant
- DYNAL BIOTECH, INC.
- 510(k) number
- K873185
- Product code
- JCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-04
- Date received
- 1987-08-12
- 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
- BARBARA A SAWITSKY
- Address
- 45 N. Station Plz. Great Neck NY US 11021 11021
FDA Registration Numbers#
- 1917413
- 3013221738
- 3006158025
- 3013058950
- 3000178104
- 2243072
- 3030625683
- 3004450619
- 3009573214
- 3005182159
- 1114298
- 2024375
- 8010134
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 |
| K874328 | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | E.I. Dupont DE Nemours & Co., Inc. | 1988-02-16 |
| 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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