The following data is part of a premarket notification filed by Innovita (tangshan) Biological Technology Co., Ltd with the FDA for Innovita Hcg Pregnancy Rapid Test Strip, Innovita Hcg Pregnancy Rapid Test Cassette, Innovita Hcg Pregnancy Rapid Test Midstream.
| Device ID | K192843 |
| 510k Number | K192843 |
| Device Name: | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Innovita (Tangshan) Biological Technology Co., Ltd No. 699 Juxin Street, High-tech Industrial Development Zone Qian'an, CN 064400 |
| Contact | Leo Lee |
| Correspondent | Fiona Wang Huajian US Services 19800 MacArthur Blvd, Ste 420 Irvine, CA 92612 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-03 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011389224 | K192843 | 000 |