The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen One Step Methamphetamine Test(9065).
| Device ID | K972556 |
| 510k Number | K972556 |
| Device Name: | QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Contact | Tuan H Pham |
| Correspondent | Tuan H Pham PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-09 |
| Decision Date | 1997-09-02 |
| Summary: | summary |