MICROMEDIC MORPHINE RIA KIT
FDA 510(k) clearance K881102 · decided 1988-06-24
Clearance details
- K-number
- K881102
- Device name
- MICROMEDIC MORPHINE RIA KIT
- Applicant
- Icn Micromedic Systems
- Decision
- Substantially Equivalent
- Date received
- 1988-03-15
- Decision date
- 1988-06-24
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- DOE
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.