The following data is part of a premarket notification filed by Assure Tech. Co., Ltd. with the FDA for Assure Tech Hcg Pregnancy Serum/urine Combo Test Cassette, Assure Tech Hcg Pregnancy Serum/urine Combo Test Strip.
| Device ID | K152768 |
| 510k Number | K152768 |
| Device Name: | Assure Tech HCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech HCG Pregnancy Serum/Urine Combo Test Strip |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ASSURE TECH. CO., LTD. 2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD, Hangzhou, CN 310030 |
| Contact | Eric Lin |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2016-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804801830 | K152768 | 000 |
| 06952804801212 | K152768 | 000 |
| 06952804801205 | K152768 | 000 |
| 06952804801090 | K152768 | 000 |