INNOFLOUR TOPIRAMATE REAGENT SET
FDA 510(k) clearance K970510 · decided 1997-05-12
Clearance details
- K-number
- K970510
- Device name
- INNOFLOUR TOPIRAMATE REAGENT SET
- Applicant
- Oxis Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-11
- Decision date
- 1997-05-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MSL
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.