Lympho Sep(Tm)
FDA 510(k) K902445 · Icn Biomedicals, Inc.
510(k) numberK902445
Submission
- Device name
- Lympho Sep(Tm)
- Applicant
- Icn Biomedicals, Inc.
Costa Mesa, CA, US - Received
- June 1, 1990
- Decision date
- August 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCF – Lymphocyte Separation Medium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8500
- Specialty
- Hematology
Other 510(k)s with product code JCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911731 | Leucoprep(R) Brand Cell Separat Tube W/Sodium CitrJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/15/1992SE |
| K891407 | Leucoprep Cell Separation TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/26/1989SE |
| K874328 | L-Phenylalanine Methyl Ester Hydrochloride Pme ReaJCF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/16/1988SE |
| K873185 | Dynabeads Hla Cell Prep II Isolation ProductJCF · Traditional | Dynal Biotech, Inc. | 11/04/1987SE |
| K872775 | Leucoprep Brand TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/02/1987SE |
| K860354 | Sepracell Lymphocyte Separation MediumJCF · Traditional | Sepratech Corporation C/O Keller and Heckman | 04/18/1986SE |
| K854093 | Leuco PrepJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/12/1985SE |
| K842818 | CSTJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/23/1984SE |
| K842146 | HISTOPAQUE-1077JCF · Traditional | Sigma Chemical Co. | 07/27/1984SE |
| K812947 | Mono-Poly Resolving MediumJCF · Traditional | Flow Laboratories, Inc. | 03/11/1982SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030211 | Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016DKX · Traditional | 06/13/2003SE |
| K023252 | Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020DJR · Traditional | 11/22/2002SE |
| K926106 | Immuchem Phe-Mw EaJNB · Traditional | 02/08/1995SE |
| K922944 | Immuchem Lh-Mw ElisaCEP · Traditional | 02/02/1993SE |
| K922715 | Immuchem Prl-Mw ElisaCFT · Traditional | 10/05/1992SE |
| K922376 | Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa KitCGJ · Traditional | 10/05/1992SE |
| K920442 | Immuchem Tsh-Mw ElisaJLW · Traditional | 03/18/1992SE |
| K913963 | Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional | 12/13/1991SE |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. RiaJLX · Traditional | 02/23/1989SE |
| K881005 | Immuchem Human Chorionic Gonadotropin Hormone HCGJHI · Traditional | 05/27/1988SE |
Questions and answers
When was Lympho Sep(Tm) cleared by the FDA?
Lympho Sep(Tm) (K902445) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 82 days after the submission was received.
What is the product code of K902445?
The FDA product code is JCF – Lymphocyte Separation Medium, a Class I (low risk) device regulated under 21 CFR 864.8500.