ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE— 510(k) K012595
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K012595 for ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE, Substantially Equivalent on 2001-10-15. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.