FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme DZ-Lite Total beta-hCG Test System
K Number: K163418
·
Decision Aug 18, 2017
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
41
Review Days
255
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Basic Information
- Device Name
- Diazyme DZ-Lite Total beta-hCG Test System
- K Number
- K163418
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- December 6, 2016
- Decision Date
- August 18, 2017
- 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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