FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OVULON MONITOR
K Number: K973860
·
Decision Jan 7, 1998
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
5
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- OVULON MONITOR
- K Number
- K973860
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conception Technology, Inc.
- Date Received
- October 9, 1997
- Decision Date
- January 7, 1998
- 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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