FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Allerhope Allergy Skin Tester
K Number: K162917
·
Decision Aug 17, 2017
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
24
Applicant Total
1
Review Days
303
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Basic Information
- Device Name
- Allerhope Allergy Skin Tester
- K Number
- K162917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procare Industrial Co., Limited
- Date Received
- October 18, 2016
- Decision Date
- August 17, 2017
- Product Code
- SCL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| SCL | Allergen And Vaccine Delivery Needles | FDA class 2 | General Hospital |
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