FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOLLICLE STIMULATING HORMONE (HFSH)
K Number: K871317
·
Decision May 20, 1987
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
18
Review Days
48
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Basic Information
- Device Name
- FOLLICLE STIMULATING HORMONE (HFSH)
- K Number
- K871317
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- April 2, 1987
- Decision Date
- May 20, 1987
- 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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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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GENUA MENOPAUSE MONITOR TEST KIT
FDA 510(k)
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Other Clearances by Immuchem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Dec 15, 1988 | Substantially Equivalent |
| K871542 | HPROLACTIN KIT | May 14, 1987 | Substantially Equivalent |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Mar 13, 1987 | Substantially Equivalent |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | Nov 24, 1986 | Substantially Equivalent |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Mar 14, 1986 | Substantially Equivalent |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Feb 28, 1986 | Substantially Equivalent |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | May 4, 1983 | Substantially Equivalent |
| K822509 | COVALENT COAT RIA KIT | Sep 28, 1982 | Substantially Equivalent |
| K822140 | IMMUCHEM COVALENT-COAT | Aug 5, 1982 | Substantially Equivalent |
| K820329 | ESTRADIOL KIT BY RIA | Mar 4, 1982 | Substantially Equivalent |