Immuno-Cell Immuno-Sep Kit
FDA 510(k) K812411 · Kallestad Laboratories, Inc.
510(k) numberK812411
Submission
- Device name
- Immuno-Cell Immuno-Sep Kit
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- August 21, 1981
- Decision date
- November 10, 1981
- 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 |
| K902445 | Lympho Sep(Tm)JCF · Traditional | Icn Biomedicals, Inc. | 08/22/1990SE |
| 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 |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Immuno-Cell Immuno-Sep Kit cleared by the FDA?
Immuno-Cell Immuno-Sep Kit (K812411) received a 510(k) decision of Substantially Equivalent on November 10, 1981, 81 days after the submission was received.
What is the product code of K812411?
The FDA product code is JCF – Lymphocyte Separation Medium, a Class I (low risk) device regulated under 21 CFR 864.8500.