VISUALINE METHADONE DIPSTRIPTEST
FDA 510(k) clearance K023856 · decided 2003-08-25
Clearance details
- K-number
- K023856
- Device name
- VISUALINE METHADONE DIPSTRIPTEST
- Applicant
- Sun Biomedical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-19
- Decision date
- 2003-08-25
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Blackwood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.