HISTOPAQUE-1077
FDA 510(k) K842146 · Sigma Chemical Co.
510(k) numberK842146
Submission
- Device name
- HISTOPAQUE-1077
- Applicant
- Sigma Chemical Co.
Walker, MI, US - Received
- May 30, 1984
- Decision date
- July 27, 1984
- 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 |
| K812947 | Mono-Poly Resolving MediumJCF · Traditional | Flow Laboratories, Inc. | 03/11/1982SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was HISTOPAQUE-1077 cleared by the FDA?
HISTOPAQUE-1077 (K842146) received a 510(k) decision of Substantially Equivalent on July 27, 1984, 58 days after the submission was received.
What is the product code of K842146?
The FDA product code is JCF – Lymphocyte Separation Medium, a Class I (low risk) device regulated under 21 CFR 864.8500.