FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOLLICLE STIMULATING HORMONE (FSH) KIT
K Number: K792063
·
Decision Nov 20, 1979
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
9
Review Days
36
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Basic Information
- Device Name
- FOLLICLE STIMULATING HORMONE (FSH) KIT
- K Number
- K792063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cis Radiopharmaceuticals, Inc.
- Date Received
- October 15, 1979
- Decision Date
- November 20, 1979
- Product Code
- CGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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.
ONE STEP FSH MENOPAUSAL TEST
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MOMENTS MENOPAUSE CHECK, MODEL 9113
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FSH MENOPAUSE PREDICTOR TEST
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PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
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EARLYDETECT MENOPAUSE TEST FOR FSH
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FDA Class 1
·Clinical Chemistry
GENUA MENOPAUSE MONITOR TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Cis Radiopharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791860 | FERRITIN RIA KIT | Dec 6, 1979 | Substantially Equivalent |
| K791202 | RIA KIT FOR TRYPSIN | Nov 5, 1979 | Substantially Equivalent |
| K792000 | LUTEINIZING HORMONE (LH) RIA | Oct 30, 1979 | Substantially Equivalent |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | Jul 24, 1979 | Substantially Equivalent |
| K790003 | RIA KIT, PROLACTIN | Mar 12, 1979 | Substantially Equivalent |
| K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT | Jun 22, 1978 | Substantially Equivalent |
| K771878 | IRIDIUM 192 WIRES & PINS | Oct 27, 1977 | Substantially Equivalent |
| K760251 | SET, ORAL ADMINISTRATION | Sep 15, 1976 | Substantially Equivalent |