FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
S/P VORTEX MIXER JR.
K Number: K813149
·
Decision Nov 24, 1981
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
7
Applicant Total
149
Review Days
18
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Basic Information
- Device Name
- S/P VORTEX MIXER JR.
- K Number
- K813149
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- November 6, 1981
- Decision Date
- November 24, 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.
MINI-SHAKER
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 American Dade
| K Number | Device Name | ||
|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | Oct 20, 1987 | Substantially Equivalent |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 29, 1987 | Substantially Equivalent |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 14, 1987 | Substantially Equivalent |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | Sep 2, 1987 | Substantially Equivalent |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | Aug 6, 1987 | Substantially Equivalent |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | Jul 31, 1987 | Substantially Equivalent |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | Jul 6, 1987 | Substantially Equivalent |