Submission Details
| 510(k) Number | K994234 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 16, 1999 |
| Decision Date | December 30, 1999 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Special
AT HOME DRUG TEST, MODEL 9083
Dec 1999
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K994234 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9083, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999, 14 days after receiving the submission on December 16, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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