HISTO-CENTER II
FDA 510(k) clearance K792095 · decided 1979-11-20
Clearance details
- K-number
- K792095
- Device name
- HISTO-CENTER II
- Applicant
- Thermolyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-10-17
- Decision date
- 1979-11-20
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- IDW
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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.