The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening Test, Model 9317t; Cup Multi Drug Sc.
| Device ID | K070098 |
| 510k Number | K070098 |
| Device Name: | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-10 |
| Decision Date | 2007-12-07 |
| Summary: | summary |