510(k) K813148
- Device
- S/p Vortex Mixer
- Applicant
- AMERICAN DADE
- 510(k) number
- K813148
- Product code
- JRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-24
- Date received
- 1981-11-06
- Regulation
- 862.2050
- Classification name
- Shaker/Stirrer
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015505238
- 3007123908
- 9615162
- 9680836
- 3009155756
- 3027645317
- 3013530901
- 2244900
- 3010408396
- 3005592623
- 3043088937
- 3013846070
- 3043138885
- 3027555954
- 3006697110
- 3019387954
- 8021924
- 1523845
- 8043909
- 9611959
- 3016509759
- 3002821232
- 3010420046
- 3014325803
- 3014397113
- 3007517215
- 3010194621
- 3007118747
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813318 | MINI-SHAKER | Dynatech Corp. | 1981-12-17 |
| K813149 | S/P VORTEX MIXER JR. | American Dade | 1981-11-24 |
| K801145 | SMI MULTI-TUBE VORTEXER | Scientific Manufacturing Industries | 1980-06-09 |
| K790753 | DIMENSIONALL ROTATOR | American Hospital Supply Corp. | 1979-06-28 |
| K790027 | SHAKER, MODEL SH-510 | Sysmex Corp. | 1979-02-08 |
| K780543 | THERMAJUST CIRCU-TEMP | Techhnilab Instruments, Inc. | 1978-05-26 |
| K770165 | MICRO-MIX PIPETTE SHAKER | Maddak, Inc. | 1977-01-31 |