ULTRAPAK CAT. #100-0251
FDA 510(k) clearance K802690 · decided 1981-01-08
Clearance details
- K-number
- K802690
- Device name
- ULTRAPAK CAT. #100-0251
- Applicant
- Occumedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-27
- Decision date
- 1981-01-08
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HYG
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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.