HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
FDA 510(k) clearance K885091 · decided 1989-06-13
Clearance details
- K-number
- K885091
- Device name
- HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
- Applicant
- Technalysis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-12
- Decision date
- 1989-06-13
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- IBM
- Device class
- 1
- Regulation number
- 864.3600
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.