WAKO(TM) ZN TEST
FDA 510(k) clearance K863920 · decided 1987-09-16
Clearance details
- K-number
- K863920
- Device name
- WAKO(TM) ZN TEST
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-08
- Decision date
- 1987-09-16
- Days to decision
- 343 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.