The following data is part of a premarket notification filed by Assure Tech (hangzhou) Co., Ltd. with the FDA for Assuretech Methamphetamine Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup), Assuretech Phencyclidine Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup), Assuretech Marijuana Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup).
| Device ID | K161044 |
| 510k Number | K161044 |
| Device Name: | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | ASSURE TECH (HANGZHOU) CO., LTD. NO. 10, XIYUANSAN RD., WESTLAKE ECONOMIC ZONE Hangzhou, CN 310030 |
| Contact | Shisheng Ling |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | DJC |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804801793 | K161044 | 000 |
| 00722066004951 | K161044 | 000 |
| 00722066004760 | K161044 | 000 |
| 00722066004616 | K161044 | 000 |
| 00722066000588 | K161044 | 000 |
| 00722066000564 | K161044 | 000 |
| 00722066000496 | K161044 | 000 |
| 00722066000489 | K161044 | 000 |
| 00722066005132 | K161044 | 000 |
| 30810038633672 | K161044 | 000 |
| 00722066005101 | K161044 | 000 |
| 10722066000486 | K161044 | 000 |
| 06952804801786 | K161044 | 000 |
| 06952804801779 | K161044 | 000 |
| 06952804801472 | K161044 | 000 |
| 06952804801465 | K161044 | 000 |
| 06952804801458 | K161044 | 000 |
| 06952804801199 | K161044 | 000 |
| 06952804801182 | K161044 | 000 |
| 06952804801175 | K161044 | 000 |
| 00722066004968 | K161044 | 000 |
| 30810038633627 | K161044 | 000 |