FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOIMMUNOASSAY, FOLLICLE STIMULATING
K Number: K811993
·
Decision Aug 3, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- RADIOIMMUNOASSAY, FOLLICLE STIMULATING
- K Number
- K811993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Endocrine-Metabolic Center
- Date Received
- July 14, 1981
- Decision Date
- August 3, 1981
- Product Code
- CGJ
- 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 |
|---|---|---|---|
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGJ), ordered by most recent decision date.
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EARLYDETECT MENOPAUSE TEST FOR FSH
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GENUA MENOPAUSE MONITOR TEST KIT
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Other Clearances by Endocrine-Metabolic Center
| K Number | Device Name | ||
|---|---|---|---|
| K821131 | RADIOIMMUNOASSAY PARATHYROID HORMONE MID | Jun 2, 1982 | Substantially Equivalent |
| K811994 | RADIOIMMUNOASSAY LUTEINIZING HORMONE | Jul 27, 1981 | Substantially Equivalent |
| K810948 | RADIOIMMUNOASSAY THYROID STIM. HORM. KIT | Apr 17, 1981 | Substantially Equivalent |
| K810351 | RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE | Feb 23, 1981 | Substantially Equivalent |
| K800188 | EMC-M-180, T3 UPTAKE - 100 TUBES | Feb 13, 1980 | Substantially Equivalent |
| K800187 | EMC-M-175, THYROXINE - 100 TUBES | Feb 13, 1980 | Substantially Equivalent |
| K790602 | RIA, DIGNXIN-125-I | Jul 30, 1979 | Substantially Equivalent |
| K790630 | RIA, INSULIN, DOUBLE ANTIBODY | Jul 24, 1979 | Substantially Equivalent |