The following data is part of a premarket notification filed by Procare Industrial Co., Limited with the FDA for Allerhope Allergy Skin Tester.
| Device ID | K162917 |
| 510k Number | K162917 |
| Device Name: | Allerhope Allergy Skin Tester |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | PROCARE INDUSTRIAL CO., LIMITED NO.5-2-9-160, SCIENCE AVENUE 89 HI-TECH ZONE Zhengzhou, CN 450000 |
| Contact | Wang Yanhong |
| Correspondent | Jonathan Hu GEBIAO STANDARD (SHANGHAI) YANGPU DISTRICT LIAOYUAN EAST ROAD SHANGYANG FIRST SUITE NO.33 ROOM 303 Shanghai, CN 200093 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-18 |
| Decision Date | 2017-08-17 |
| Summary: | summary |