The following data is part of a premarket notification filed by Assure Tech. Co., Ltd. with the FDA for Assuretech Buprenorphine Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup), Assuretech Methadone Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup).
| Device ID | K152025 |
| 510k Number | K152025 |
| Device Name: | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804801731 | K152025 | 000 |
| 06952804801724 | K152025 | 000 |
| 06952804801410 | K152025 | 000 |
| 06952804801403 | K152025 | 000 |
| 06952804801397 | K152025 | 000 |
| 06952804801137 | K152025 | 000 |
| 06952804801120 | K152025 | 000 |