ONE STEP MORPHINE CARD TEST
FDA 510(k) clearance K970579 · decided 1997-07-03
Clearance details
- K-number
- K970579
- Device name
- ONE STEP MORPHINE CARD TEST
- Applicant
- Teco Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1997-02-14
- Decision date
- 1997-07-03
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DNK
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.