FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYROID STIMULATING HORMONE
K Number: K792154
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
240
Applicant Total
9
Review Days
19
Basic Information
- Device Name
- THYROID STIMULATING HORMONE
- K Number
- K792154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- RADIOIMMUNOASSAY, INC.
- Date Received
- October 25, 1979
- Decision Date
- November 13, 1979
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 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 |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | Oct 30, 1979 | Substantially Equivalent |
| K780671 | 125 I-T3 UPTAKE REAGENT | Jun 6, 1978 | Substantially Equivalent |
| K780672 | 125 I-T4 RIA REAGENT | Jun 6, 1978 | Substantially Equivalent |