ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
FDA 510(k) clearance K040629 · decided 2004-05-05
Clearance details
- K-number
- K040629
- Device name
- ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
- Applicant
- Accu-Stat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-10
- Decision date
- 2004-05-05
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LDJ
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.