FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K Number: K060452
·
Decision Mar 13, 2007
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
1
Review Days
385
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Basic Information
- Device Name
- ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
- K Number
- K060452
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neo-Genesis
- Date Received
- February 21, 2006
- Decision Date
- March 13, 2007
- Product Code
- JLX
- 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 |
|---|---|---|---|
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | FDA class 1 | Clinical Chemistry |
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