GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
FDA 510(k) clearance K772031 · decided 1977-11-14
Clearance details
- K-number
- K772031
- Device name
- GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
- Applicant
- Harleco
- Decision
- Substantially Equivalent
- Date received
- 1977-10-27
- Decision date
- 1977-11-14
- Days to decision
- 18 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.