FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUID, RHEMOX W LYSING
K Number: K790029
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
18
Review Days
54
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Basic Information
- Device Name
- FLUID, RHEMOX W LYSING
- K Number
- K790029
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sysmex Corp.
- Date Received
- January 3, 1979
- Decision Date
- February 26, 1979
- Product Code
- GGK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | Hematology |
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Other Clearances by Sysmex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K012372 | SYSMEX UF-50 | Sep 28, 2001 | Substantially Equivalent |
| K992875 | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER | Nov 9, 1999 | Substantially Equivalent |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | Nov 3, 1998 | Substantially Equivalent |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | Aug 14, 1998 | Substantially Equivalent |
| K971736 | SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER | Aug 26, 1997 | Substantially Equivalent |
| K964946 | SYSMEX CA-1000/SYSMEX CA-5000 | Mar 18, 1997 | Substantially Equivalent |
| K964375 | SYSMEX SE/RAM-1 | Mar 13, 1997 | Substantially Equivalent |
| K961054 | SYSMEX UF-100 | Oct 28, 1996 | Substantially Equivalent |
| K950508 | SYSMEX SF-3000 | Nov 3, 1995 | Substantially Equivalent |
| K945837 | SYSMEX(TM) F-820, 520 | Jun 9, 1995 | Substantially Equivalent |