FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T-3 RIASSAY
K Number: K852537
·
Decision Aug 12, 1985
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
7
Review Days
59
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Basic Information
- Device Name
- T-3 RIASSAY
- K Number
- K852537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ria Diagnostics
- Date Received
- June 14, 1985
- Decision Date
- August 12, 1985
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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AIA-PACK FT3 ASSAY
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OPTICOAT T3 EIA KIT
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ABBOTT ARCHITECT FREE T3
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 |
| K854798 | T-4 RIASSAY | Jan 15, 1986 | 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 |