The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Polymed Therapeutics Fastep Dipstick Drugs Of Abuse Screen Device And Dipcard Drugs Of Abuse Screen Device.
| Device ID | K121065 |
| 510k Number | K121065 |
| Device Name: | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | POLYMED THERAPEUTICS, INC 12828 DOE LANE Gaithersburg, MD 20878 |
| Contact | Jj Xia |
| Correspondent | Jj Xia POLYMED THERAPEUTICS, INC 12828 DOE LANE Gaithersburg, MD 20878 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2013-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066003701 | K121065 | 000 |
| 00722066000779 | K121065 | 000 |
| 00722066000762 | K121065 | 000 |
| 00722066000731 | K121065 | 000 |
| 00722066000724 | K121065 | 000 |
| 00722066000670 | K121065 | 000 |
| 00722066000663 | K121065 | 000 |
| 00722066000618 | K121065 | 000 |
| 00722066000601 | K121065 | 000 |
| 00722066000557 | K121065 | 000 |
| 00722066000540 | K121065 | 000 |
| 00722066000533 | K121065 | 000 |
| 00722066000526 | K121065 | 000 |
| 00722066000519 | K121065 | 000 |
| 00722066000502 | K121065 | 000 |
| 00722066000458 | K121065 | 000 |
| 00722066000441 | K121065 | 000 |
| 00722066000595 | K121065 | 000 |
| 00722066000786 | K121065 | 000 |
| 00722066000793 | K121065 | 000 |
| 00722066003695 | K121065 | 000 |
| 00722066003688 | K121065 | 000 |
| 00722066003671 | K121065 | 000 |
| 00722066003664 | K121065 | 000 |
| 00722066003657 | K121065 | 000 |
| 00722066003541 | K121065 | 000 |
| 00722066003459 | K121065 | 000 |
| 00722066003428 | K121065 | 000 |
| 00722066003312 | K121065 | 000 |
| 00722066003107 | K121065 | 000 |
| 00722066000915 | K121065 | 000 |
| 00722066000908 | K121065 | 000 |
| 00722066000892 | K121065 | 000 |
| 00722066000885 | K121065 | 000 |
| 00722066000847 | K121065 | 000 |
| 00722066000830 | K121065 | 000 |
| 00722066000809 | K121065 | 000 |
| 00722066000571 | K121065 | 000 |