S/P Vortex Mixer
FDA 510(k) K813148 · American Dade
510(k) numberK813148
Submission
- Device name
- S/P Vortex Mixer
- Applicant
- American Dade
Mchenry, IL, US - Received
- November 6, 1981
- Decision date
- November 24, 1981
- 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 |
| K801145 | Smi Multi-Tube VortexerJRQ · Traditional | Scientific Manufacturing Industries | 06/09/1980SE |
| K790753 | Dimensionall RotatorJRQ · Traditional | American Hospital Supply Corp. | 06/28/1979SE |
| K790027 | Shaker, Model SH-510JRQ · Traditional | Sysmex Corp. | 02/08/1979SE |
| 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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| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was S/P Vortex Mixer cleared by the FDA?
S/P Vortex Mixer (K813148) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 18 days after the submission was received.
What is the product code of K813148?
The FDA product code is JRQ – Shaker/Stirrer, a Class I (low risk) device regulated under 21 CFR 862.2050.