Fluid, Rhemox W Lysing
FDA 510(k) K790029 · Sysmex Corp.
510(k) numberK790029
Submission
- Device name
- Fluid, Rhemox W Lysing
- Applicant
- Sysmex Corp.
Mchenry, IL, US - Received
- January 3, 1979
- Decision date
- February 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGK – Products, Red-Cell Lysing Products
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8540
- Specialty
- Hematology
Other 510(k)s with product code GGK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883836 | Coulter Clone Quick Stain Whole Blood Lyse-IiGGK · Traditional | Coulter Immunology | 11/30/1988SE |
| K883991 | KVM Hemoglobin Lysing ReagentGGK · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | Fisher Scientific Co., LLC | 10/20/1987SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | Abbott Diagnostics | 09/09/1987SE |
| K863114 | PiastrinitGGK · Traditional | J. D. Assoc. | 11/06/1986SE |
| K863503 | HemolyseGGK · Traditional | Reagent Laboratory, Inc. | 10/03/1986SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | Nobel Scientific Industries, Inc. | 03/29/1985SE |
| K850097 | Laser-LyseGGK · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | E K Ind., Inc. | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | E K Ind., Inc. | 09/12/1984SE |
More from E K Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012372 | Sysmex UF-50LKM · Traditional | 09/28/2001SE |
| K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional | 11/09/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | 08/14/1998SE |
| K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional | 08/26/1997SE |
| K964946 | Sysmex CA-1000/SYSMEX CA-5000JPA · Traditional | 03/18/1997SE |
| K964375 | Sysmex SE/RAM-1GKL · Traditional | 03/13/1997SE |
| K961054 | Sysmex UF-100LKM · Traditional | 10/28/1996SE |
| K950508 | Sysmex SF-3000FPK · Traditional | 11/03/1995SE |
| K945837 | Sysmex(Tm) F-820, 520GKZ · Traditional | 06/09/1995SE |
Questions and answers
When was Fluid, Rhemox W Lysing cleared by the FDA?
Fluid, Rhemox W Lysing (K790029) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 54 days after the submission was received.
What is the product code of K790029?
The FDA product code is GGK – Products, Red-Cell Lysing Products, a Class I (low risk) device regulated under 21 CFR 864.8540.