FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHAKER, MODEL SH-510
K Number: K790027
·
Decision Feb 8, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
7
Applicant Total
18
Review Days
36
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Basic Information
- Device Name
- SHAKER, MODEL SH-510
- K Number
- K790027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sysmex Corp.
- Date Received
- January 3, 1979
- Decision Date
- February 8, 1979
- Product Code
- JRQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JRQ | Shaker/Stirrer | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRQ), ordered by most recent decision date.
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S/P VORTEX MIXER JR.
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SMI MULTI-TUBE VORTEXER
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DIMENSIONALL ROTATOR
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THERMAJUST CIRCU-TEMP
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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 |