ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE— 510(k) K012300
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K012300 for ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE, Substantially Equivalent on 2001-09-17. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code JXM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3170
- 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.