FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
125 I-T3 UPTAKE REAGENT
K Number: K780671
·
Decision Jun 6, 1978
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
24
Applicant Total
9
Review Days
43
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Basic Information
- Device Name
- 125 I-T3 UPTAKE REAGENT
- K Number
- K780671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1685
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioimmunoassay, Inc.
- Date Received
- April 24, 1978
- Decision Date
- June 6, 1978
- Product Code
- CEE
- 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 |
|---|---|---|---|
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Radioimmunoassay, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT | Oct 10, 1980 | Substantially Equivalent |
| K800106 | LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS | Feb 13, 1980 | Substantially Equivalent |
| K800107 | FOLLICLE STIMULATING HORMONE | Feb 13, 1980 | Substantially Equivalent |
| K792539 | TRIIODOTHYRONINE RIA SYSTEM | Jan 16, 1980 | Substantially Equivalent |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Nov 13, 1979 | Substantially Equivalent |
| K792154 | THYROID STIMULATING HORMONE | Nov 13, 1979 | Substantially Equivalent |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | Oct 30, 1979 | Substantially Equivalent |
| K780672 | 125 I-T4 RIA REAGENT | Jun 6, 1978 | Substantially Equivalent |