The following data is part of a premarket notification filed by Assure Tech. Co., Ltd with the FDA for Assuretech Secobarbital Strip, Assuretech Oxycodone Strip, Assuretech Secobarbital/oxycodone Panel Dip, Assuretech Secobarbital/oxycodone Quick Cup, Assuretech Secobarbital/oxycodone Turn Key-split Cup.
| Device ID | K151211 |
| 510k Number | K151211 |
| Device Name: | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804801717 | K151211 | 000 |
| 06952804801700 | K151211 | 000 |
| 06952804801298 | K151211 | 000 |
| 06952804801236 | K151211 | 000 |
| 06952804801113 | K151211 | 000 |
| 06952804801106 | K151211 | 000 |
| 06952804801083 | K151211 | 000 |