The following data is part of a premarket notification filed by Assure Tech (hangzhou) Co., Ltd. with the FDA for Assuretech Amphetamine Tests (strip, Dip Card, Quick Cup, Turn-key Split Cup), Assuretech Cocaine Tests (strip, Dip Card, Quick Cup, Turn-key Split Cup), Assuretech Morphine Tests (strip, Dip Card, Quick Cup, Turn-key Split Cup).
| Device ID | K153465 |
| 510k Number | K153465 |
| Device Name: | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-01 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804801762 | K153465 | 000 |
| 06952804801755 | K153465 | 000 |
| 06952804801748 | K153465 | 000 |
| 06952804801441 | K153465 | 000 |
| 06952804801434 | K153465 | 000 |
| 06952804801427 | K153465 | 000 |
| 06952804801168 | K153465 | 000 |
| 06952804801151 | K153465 | 000 |
| 06952804801144 | K153465 | 000 |