MINI-SHAKER
FDA 510(k) clearance K813318 · decided 1981-12-17
Clearance details
- K-number
- K813318
- Device name
- MINI-SHAKER
- Applicant
- Dynatech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-24
- Decision date
- 1981-12-17
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JRQ
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| S/P VORTEX MIXER JR. (K813149) | American Dade | 1981-11-24 |
| S/P VORTEX MIXER (K813148) | American Dade | 1981-11-24 |
| SMI MULTI-TUBE VORTEXER (K801145) | Scientific Manufacturing Industries | 1980-06-09 |
| DIMENSIONALL ROTATOR (K790753) | American Hospital Supply Corp. | 1979-06-28 |
| SHAKER, MODEL SH-510 (K790027) | Sysmex Corp. | 1979-02-08 |
| THERMAJUST CIRCU-TEMP (K780543) | Techhnilab Instruments, Inc. | 1978-05-26 |
| MICRO-MIX PIPETTE SHAKER (K770165) | Maddak, Inc. | 1977-01-31 |
Recalls involving this device
No recalls on record reference this clearance.