Submission Details
| 510(k) Number | K040629 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2004 |
| Decision Date | May 05, 2004 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
K040629 - ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
(FDA 510(k) Clearance)
May 2004
Decision
56d
Days
Class 2
Risk
K040629 is an FDA 510(k) clearance for the ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ).
Submitted by Accu-Stat Diagnostics, Inc. (Lake Forest, US). The FDA issued a Cleared decision on May 5, 2004, 56 days after receiving the submission on March 10, 2004.
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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