ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE— 510(k) K041822
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K041822 for ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE, Substantially Equivalent on 2004-09-16. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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