ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
FDA 510(k) clearance K060354 · decided 2006-07-28
Clearance details
- K-number
- K060354
- Device name
- ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
- Applicant
- Acro Biotech, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-02-13
- Decision date
- 2006-07-28
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- JXM
- Device class
- 2
- Regulation number
- 862.3170
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rancho Cucamonga, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.