UROPAPER EIKEN 6B
FDA 510(k) clearance K932368 · decided 1994-01-13
Clearance details
- K-number
- K932368
- Device name
- UROPAPER EIKEN 6B
- Applicant
- Tanabe U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-19
- Decision date
- 1994-01-13
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.