SMAC REPLACEMENT REAGENTS, WETTING AGENT
FDA 510(k) clearance K800670 · decided 1980-04-16
Clearance details
- K-number
- K800670
- Device name
- SMAC REPLACEMENT REAGENTS, WETTING AGENT
- Applicant
- Diagnostic Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-26
- Decision date
- 1980-04-16
- Days to decision
- 21 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.