Submission Details
| 510(k) Number | K070098 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2007 |
| Decision Date | December 07, 2007 |
| Days to Decision | 331 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
Dec 2007
Decision
331d
Days
Class 2
Risk
About This 510(k) Submission
K070098 is an FDA 510(k) clearance for the QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 7, 2007, 331 days after receiving the submission on January 10, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.
Device Classification
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3150 |
Manufacturer
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