FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
K Number: K981761
·
Decision Aug 14, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
18
Review Days
87
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Basic Information
- Device Name
- SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
- K Number
- K981761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sysmex Corp.
- Date Received
- May 19, 1998
- Decision Date
- August 14, 1998
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | 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 |
| 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 |
| K942097 | TOA MEDICAL ELECTRONICS CA-5000 | Mar 24, 1995 | Substantially Equivalent |