Dimensionall Rotator
FDA 510(k) K790753 · American Hospital Supply Corp.
510(k) numberK790753
Submission
- Device name
- Dimensionall Rotator
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- April 17, 1979
- Decision date
- June 28, 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 |
| 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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| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | 05/25/1983SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
Questions and answers
When was Dimensionall Rotator cleared by the FDA?
Dimensionall Rotator (K790753) received a 510(k) decision of Substantially Equivalent on June 28, 1979, 72 days after the submission was received.
What is the product code of K790753?
The FDA product code is JRQ – Shaker/Stirrer, a Class I (low risk) device regulated under 21 CFR 862.2050.