FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T-4 RIASSAY
K Number: K854798
·
Decision Jan 15, 1986
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- T-4 RIASSAY
- K Number
- K854798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ria Diagnostics
- Date Received
- December 2, 1985
- Decision Date
- January 15, 1986
- Product Code
- CDX
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
ELECSYS T4 ASSAY
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ACTIVE THYROXINE RIA
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DELFIA NEONATAL THYROXINE KIT
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AXSYM(TM) TOTAL T4
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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Ria Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K855033 | T-3 UPTAKE/RIASSAY | Jan 24, 1986 | Substantially Equivalent |
| K852537 | T-3 RIASSAY | Aug 12, 1985 | Substantially Equivalent |
| K810296 | DIGOXIN RIA ASSAY | Feb 19, 1981 | Substantially Equivalent |
| K801691 | TSH RIASSAY | Aug 27, 1980 | Substantially Equivalent |
| K792062 | THEOPHYLLINE RIASSAY | Feb 25, 1980 | Substantially Equivalent |
| K780012 | ANTITHROMBIN III RIA | Jan 20, 1978 | Substantially Equivalent |