FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOLLICE STIMULATING HORMONE-RADIOIMM. KT
K Number: K803279
·
Decision Jan 16, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
30
Review Days
18
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Basic Information
- Device Name
- FOLLICE STIMULATING HORMONE-RADIOIMM. KT
- K Number
- K803279
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuno Nuclear Corp.
- Date Received
- December 29, 1980
- Decision Date
- January 16, 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 Immuno Nuclear Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT | Dec 15, 1986 | Substantially Equivalent |
| K863973 | ELM ALLERGEN DISC | Dec 1, 1986 | Substantially Equivalent |
| K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC | Oct 29, 1986 | Substantially Equivalent |
| K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC | Oct 1, 1986 | Substantially Equivalent |
| K863098 | MEADOW FESCUE ALLERGEN DISC | Sep 15, 1986 | Substantially Equivalent |
| K862266 | MAPLE ALLERGEN DISC | Aug 19, 1986 | Substantially Equivalent |
| K862938 | JUNE GRASS ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862176 | RUSSIAN THISTLE ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862265 | COTTONWOOD ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862939 | ORCHARD GRASS ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |