Shaker, Model SH-510
FDA 510(k) K790027 · Sysmex Corp.
510(k) numberK790027
Submission
- Device name
- Shaker, Model SH-510
- Applicant
- Sysmex Corp.
Mchenry, IL, US - Received
- January 3, 1979
- Decision date
- February 8, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRQ – Shaker/Stirrer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K813318 | Mini-ShakerJRQ · Traditional | Dynatech Corp. | 12/17/1981SE |
| K813149 | S/P Vortex Mixer Jr.JRQ · Traditional | American Dade | 11/24/1981SE |
| K813148 | S/P Vortex MixerJRQ · Traditional | American Dade | 11/24/1981SE |
| K801145 | Smi Multi-Tube VortexerJRQ · Traditional | Scientific Manufacturing Industries | 06/09/1980SE |
| K790753 | Dimensionall RotatorJRQ · Traditional | American Hospital Supply Corp. | 06/28/1979SE |
| K780543 | Thermajust Circu-TempJRQ · Traditional | Techhnilab Instruments, Inc. | 05/26/1978SE |
| K770165 | Micro-Mix Pipette ShakerJRQ · Traditional | Maddak, Inc. | 01/31/1977SE |
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| 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 Shaker, Model SH-510 cleared by the FDA?
Shaker, Model SH-510 (K790027) received a 510(k) decision of Substantially Equivalent on February 8, 1979, 36 days after the submission was received.
What is the product code of K790027?
The FDA product code is JRQ – Shaker/Stirrer, a Class I (low risk) device regulated under 21 CFR 862.2050.