WAKO CH50 LINEARITY SET
FDA 510(k) clearance K973055 · decided 1997-09-25
Clearance details
- K-number
- K973055
- Device name
- WAKO CH50 LINEARITY SET
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-15
- Decision date
- 1997-09-25
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JIW
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.