COZART EIA OPIATES ORAL FLUID KIT
FDA 510(k) clearance K024339 · decided 2003-04-07
Clearance details
- K-number
- K024339
- Device name
- COZART EIA OPIATES ORAL FLUID KIT
- Applicant
- Cozart Bioscience , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-27
- Decision date
- 2003-04-07
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- DIG
- Device class
- 1
- Regulation number
- 862.3240
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Oxfordshire Ox14 4ru, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.