FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FSH MENOPAUSE PREDICTOR TEST
K Number: K041165
·
Decision Jun 17, 2004
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
85
Review Days
44
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Basic Information
- Device Name
- FSH MENOPAUSE PREDICTOR TEST
- K Number
- K041165
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- May 4, 2004
- Decision Date
- June 17, 2004
- 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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FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
FDA 510(k)
FDA Class 1
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