Shaker/Stirrer
The Shaker/Stirrer is a clinical laboratory instrument used to agitate, shake, or stir biological specimens, reagents, or mixtures at controlled speeds to facilitate reactions, ensure homogeneous mixing, and prevent sedimentation during clinical chemistry assay procedures. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRQ and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JRQ
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K813318 | MINI-SHAKER | Dec 17, 1981 | Substantially Equivalent | Dynatech Corp. |
| K813149 | S/P VORTEX MIXER JR. | Nov 24, 1981 | Substantially Equivalent | American Dade |
| K813148 | S/P VORTEX MIXER | Nov 24, 1981 | Substantially Equivalent | American Dade |
| K801145 | SMI MULTI-TUBE VORTEXER | Jun 09, 1980 | Substantially Equivalent | Scientific Manufacturing Industries |
| K790753 | DIMENSIONALL ROTATOR | Jun 28, 1979 | Substantially Equivalent | American Hospital Supply Corp. |
| K790027 | SHAKER, MODEL SH-510 | Feb 08, 1979 | Substantially Equivalent | Sysmex Corp. |
| K780543 | THERMAJUST CIRCU-TEMP | May 26, 1978 | Substantially Equivalent | Techhnilab Instruments, Inc. |
| K770165 | MICRO-MIX PIPETTE SHAKER | Jan 31, 1977 | Substantially Equivalent | Maddak, Inc. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.