The following data is part of a premarket notification filed by Qingdao Hightop Biotech Co., Ltd. with the FDA for Hightop Pregnancy Rapid Test Cassette, Hightop Pregnancy Rapid Test Strip, Hightop Pregnancy Rapid Test Midstream.
| Device ID | K192123 |
| 510k Number | K192123 |
| Device Name: | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Qingdao Hightop Biotech Co., Ltd. No. 369 Hedong Road, Hi-tech Industrial Development Zone Qingdao, CN 266112 |
| Contact | Allen Lee |
| Correspondent | Joe Shia LSI International 504 E. Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16935091670003 | K192123 | 000 |