The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027t, 9153t And 9195x.
| Device ID | K043167 |
| 510k Number | K043167 |
| Device Name: | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2004-12-29 |
| Summary: | summary |