FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EARLYDETECT MENOPAUSE TEST FOR FSH
K Number: K030058
·
Decision Jul 30, 2003
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
1
Review Days
204
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Basic Information
- Device Name
- EARLYDETECT MENOPAUSE TEST FOR FSH
- K Number
- K030058
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Early Detect, Inc.
- Date Received
- January 7, 2003
- Decision Date
- July 30, 2003
- 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 |
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