FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
FERTILITE OV
K Number: K020808
·
Decision Sep 23, 2002
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
5
Applicant Total
1
Review Days
195
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Basic Information
- Device Name
- FERTILITE OV
- K Number
- K020808
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pheromone Sciences Corp.
- Date Received
- March 12, 2002
- Decision Date
- September 23, 2002
- Product Code
- NGE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | FDA class 1 | Clinical Chemistry |
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