WAKO(TM) FE C
FDA 510(k) clearance K874263 · decided 1987-11-23
Clearance details
- K-number
- K874263
- Device name
- WAKO(TM) FE C
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-20
- Decision date
- 1987-11-23
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JIY
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.