510(k) K162917
- Device
- Allerhope Allergy Skin Tester
- Applicant
- PROCARE INDUSTRIAL CO., LIMITED
- 510(k) number
- K162917
- Product code
- LDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-17
- Date received
- 2016-10-18
- Regulation
- 510(k) Premarket Notification
- Classification name
- System, Delivery, Allergen And Vaccine
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WANG YANHONG
- Address
- #5-2-9-160, Science Ave. 89 Hi-Tech Zone Zhengzhou CN 450000 450000
FDA Registration Numbers#
- 3009449769
- 3010132111
- 1450391
- 3030554525
- 3012620142
- 3011088743
- 3010131789
- 3008812251
- 1424263
- 8043734
- 1055876
- 3007590959
- 1061927
- 3015536286
- 1928237
- 2248704
- 3014290918
- 1011574
- 2531321
- 3002807310
- 1423507
- 3017896194
- 1047843
Source Documents#
Legacy Summary#
summary
FDA Review#
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