INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
FDA 510(k) clearance K003879 · decided 2001-05-29
Clearance details
- K-number
- K003879
- Device name
- INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
- Applicant
- Alfa Scientific Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-15
- Decision date
- 2001-05-29
- 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
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.