FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON XL HCG
K Number: K131037
·
Decision Sep 6, 2013
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
71
Review Days
144
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Basic Information
- Device Name
- LIAISON XL HCG
- K Number
- K131037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- April 15, 2013
- Decision Date
- September 6, 2013
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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