FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUIK-CHECK OVULATION PREDICTOR
K Number: K012252
·
Decision Aug 24, 2001
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
85
Review Days
37
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Basic Information
- Device Name
- QUIK-CHECK OVULATION PREDICTOR
- K Number
- K012252
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- July 18, 2001
- Decision Date
- August 24, 2001
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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