FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI-SHAKER
K Number: K813318
·
Decision Dec 17, 1981
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
7
Applicant Total
27
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MINI-SHAKER
- K Number
- K813318
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- November 24, 1981
- Decision Date
- December 17, 1981
- Product Code
- JRQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JRQ | Shaker/Stirrer | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRQ), ordered by most recent decision date.
S/P VORTEX MIXER JR.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
S/P VORTEX MIXER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMI MULTI-TUBE VORTEXER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSIONALL ROTATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SHAKER, MODEL SH-510
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMAJUST CIRCU-TEMP
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Dynatech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K904567 | DYNATECH MR4000 MICROPLATE READER | Jan 28, 1991 | Substantially Equivalent |
| K854603 | MULTI MASH 2000 | Dec 6, 1985 | Substantially Equivalent |
| K854604 | AUTO MASH | Dec 6, 1985 | Substantially Equivalent |
| K854602 | MINI MASH 2000 | Dec 6, 1985 | Substantially Equivalent |
| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | Aug 8, 1983 | Substantially Equivalent |
| K823787 | HANDI-WASH | Mar 9, 1983 | Substantially Equivalent |
| K823833 | MICRO STIX #011-010-5000 & HOLDER#5100 | Mar 8, 1983 | Substantially Equivalent |
| K830200 | MICROELISA MINIREADER II | Feb 16, 1983 | Substantially Equivalent |
| K823773 | PROVIAL II #006-010-0201 | Jan 21, 1983 | Substantially Equivalent |
| K823557 | REMOVAWELL PLATE LID | Dec 28, 1982 | Substantially Equivalent |