Submission Details
| 510(k) Number | K994220 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 1999 |
| Decision Date | December 30, 1999 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Special
K994220 - AT HOME DRUG TEST, MODEL 9078
(FDA 510(k) Clearance)
Dec 1999
Decision
15d
Days
Class 2
Risk
K994220 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9078. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ).
Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999, 15 days after receiving the submission on December 15, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
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