FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIACOAT T-4
K Number: K833745
·
Decision Jan 4, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
10
Review Days
70
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Basic Information
- Device Name
- RIACOAT T-4
- K Number
- K833745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuno Assay Corp.
- Date Received
- October 26, 1983
- Decision Date
- January 4, 1984
- 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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·Clinical Chemistry
ACTIVE THYROXINE RIA
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FDA Class 2
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DELFIA NEONATAL THYROXINE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSYM(TM) TOTAL T4
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·Clinical Chemistry
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 Immuno Assay Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833842 | RIA COAT DIGOXIN | Jan 17, 1984 | Substantially Equivalent |
| K820089 | TSH (RIA) KIT | Jan 28, 1982 | Substantially Equivalent |
| K820074 | CORTISOL (RIA) KIT | Jan 28, 1982 | Substantially Equivalent |
| K811954 | COMBO-FER IRON DIAGNOSTIC | Jul 27, 1981 | Substantially Equivalent |
| K811725 | TBG DIAGNOSTIC KIT | Jul 10, 1981 | Substantially Equivalent |
| K811213 | T3 (RIA) KIT | May 29, 1981 | Substantially Equivalent |
| K811212 | DIGOXIN (RIA) KIT | May 21, 1981 | Substantially Equivalent |
| K810857 | T3 UPTAKE KIT | Apr 8, 1981 | Substantially Equivalent |
| K810811 | T4 RIA KIT | Apr 7, 1981 | Substantially Equivalent |