The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Fastep Marijuana Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup), Fastep Methamphetamine Tests (strip, Panel Dip, Quick Cup, Turn-key Split Cup).
| Device ID | K142408 |
| 510k Number | K142408 |
| Device Name: | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | POLYMED THERAPEUTICS, INC 3040 POST OAK BLVD, SUITE 1110 Houston, TX 77056 |
| Contact | Frank Luo |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE STE.I Gaithersburg, MD 20877 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2014-09-25 |
| Summary: | summary |